Trial Outcomes & Findings for Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial (NCT NCT02285920)
NCT ID: NCT02285920
Last Updated: 2019-07-23
Results Overview
The number of participants who had serum potassium \>6.5 mEq/L was assessed by treatment arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
0 - 40 weeks
Results posted on
2019-07-23
Participant Flow
Participant milestones
| Measure |
Placebo
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
27
|
26
|
25
|
|
Overall Study
COMPLETED
|
47
|
23
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Overall Study
Kidney transplantation
|
2
|
2
|
2
|
0
|
|
Overall Study
Change to peritoneal dialysis
|
0
|
0
|
1
|
0
|
|
Overall Study
Transfer to non-participating unit
|
0
|
1
|
0
|
0
|
|
Overall Study
Dialysis discontinuation
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
2
|
0
|
2
|
1
|
Baseline Characteristics
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
55.1 years
STANDARD_DEVIATION 13.6 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
55.5 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 12.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
85 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
118 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
92 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 0 - 40 weeksThe number of participants who had serum potassium \>6.5 mEq/L was assessed by treatment arm.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Serum Potassium >6.5 mEq/L
|
9 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 0 - 40 weeksThe number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Participants With Serious Hypotension
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 0 - 36 weeksTolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Study Drug Tolerability
|
16 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline to 36 weeksPopulation: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.
Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=20 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=15 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=22 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Efficacy - Change in Mitral Annular E' Velocity
Baseline MA E'
|
7.4 cm/second
Standard Deviation 1.7
|
7.6 cm/second
Standard Deviation 1.8
|
7.8 cm/second
Standard Deviation 1.9
|
7.0 cm/second
Standard Deviation 1.9
|
|
Efficacy - Change in Mitral Annular E' Velocity
36 Week MA E'
|
7.5 cm/second
Standard Deviation 1.9
|
7.4 cm/second
Standard Deviation 1.9
|
7.7 cm/second
Standard Deviation 1.4
|
7.3 cm/second
Standard Deviation 1.9
|
|
Efficacy - Change in Mitral Annular E' Velocity
Change between baseline - 36 weeks
|
0.1 cm/second
Standard Deviation 1.1
|
-0.2 cm/second
Standard Deviation 1.0
|
-0.1 cm/second
Standard Deviation 1.2
|
0.3 cm/second
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 0 - 40 weeksAn objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Kidney transplantation
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Change to peritoneal dialysis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Transfer to non-participating facility
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Dialysis discontinued
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Death
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Feasibility of Conducting a Full-scale Mortality-powered Trial
Study completed
|
47 Participants
|
23 Participants
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 0 - 40 weeksNumber of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Number of Participants With Serious Hyperkalemia
|
6 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 0 - 40 weeksHyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Hyperkalemia Requiring Adjustment in Treatment
|
13 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 0 - 40 weeksInter- or intra-dialytic hypotension defined as: 1. Inter-dialytic: systolic blood pressure \<90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room. 2. Intra-dialytic: systolic blood pressure \<80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Inter- or Intra-dialytic Hypotension
Inter-dialytic hypotension only
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety - Inter- or Intra-dialytic Hypotension
Intra-dialytic hypotension only
|
20 Participants
|
9 Participants
|
8 Participants
|
14 Participants
|
|
Safety - Inter- or Intra-dialytic Hypotension
Inter- & intra-dialytic hypotension
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Safety - Inter- or Intra-dialytic Hypotension
No inter- or intra-dialytic hypotension
|
25 Participants
|
14 Participants
|
12 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 0 - 40 weeksNumber of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Cardiovascular Death
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline - 36 weeksPopulation: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=19 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)
LVEF Baseline
|
68.9 percent ejection fraction
Standard Deviation 4.0
|
65.9 percent ejection fraction
Standard Deviation 8.5
|
66.0 percent ejection fraction
Standard Deviation 11.4
|
68.2 percent ejection fraction
Standard Deviation 5.8
|
|
Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)
LVEF 36-Week
|
70.7 percent ejection fraction
Standard Deviation 3.1
|
66.9 percent ejection fraction
Standard Deviation 9.9
|
65.3 percent ejection fraction
Standard Deviation 13.9
|
69.5 percent ejection fraction
Standard Deviation 6.3
|
|
Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)
LVEF Change
|
1.8 percent ejection fraction
Standard Deviation 4.1
|
1.0 percent ejection fraction
Standard Deviation 4.7
|
-0.7 percent ejection fraction
Standard Deviation 7.3
|
1.3 percent ejection fraction
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline - 36 weeksPopulation: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in left ventricular mass index (LVMI) between baseline and 36 weeks
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=19 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)
LVMI Baseline
|
105.2 g/m^2
Standard Deviation 25.2
|
115.5 g/m^2
Standard Deviation 26.7
|
116.4 g/m^2
Standard Deviation 26.9
|
106.3 g/m^2
Standard Deviation 29.2
|
|
Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)
LVMI 36-Week
|
94.8 g/m^2
Standard Deviation 22.4
|
104.6 g/m^2
Standard Deviation 27.0
|
109.1 g/m^2
Standard Deviation 30.5
|
96.5 g/m^2
Standard Deviation 25.7
|
|
Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)
LVMI Change
|
-10.4 g/m^2
Standard Deviation 11.9
|
-10.9 g/m^2
Standard Deviation 18.1
|
-7.3 g/m^2
Standard Deviation 21.0
|
-9.8 g/m^2
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline - 36 weeksPopulation: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=19 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')
E/E' Baseline
|
10.7 ratio
Standard Deviation 5.8
|
11.8 ratio
Standard Deviation 6.2
|
9.2 ratio
Standard Deviation 5.0
|
12.5 ratio
Standard Deviation 5.6
|
|
Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')
E/E' 36-Week
|
11.5 ratio
Standard Deviation 7.0
|
12.2 ratio
Standard Deviation 80.
|
10.6 ratio
Standard Deviation 3.9
|
11.9 ratio
Standard Deviation 5.5
|
|
Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')
E/E' Change
|
0.9 ratio
Standard Deviation 3.6
|
0.4 ratio
Standard Deviation 4.4
|
1.4 ratio
Standard Deviation 2.2
|
-0.6 ratio
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline - 36 weeksPopulation: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in myocardial strain and strain rate between baseline and 36 weeks
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=19 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=24 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)
LVGLS Baseline
|
-17.2 % of myocardial shortening
Standard Deviation 2.8
|
-16.7 % of myocardial shortening
Standard Deviation 3.3
|
-17.2 % of myocardial shortening
Standard Deviation 4.2
|
-17.4 % of myocardial shortening
Standard Deviation 3.0
|
|
Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)
LVGLS 36-week
|
-18.1 % of myocardial shortening
Standard Deviation 2.8
|
-17.0 % of myocardial shortening
Standard Deviation 3.3
|
-17.0 % of myocardial shortening
Standard Deviation 3.9
|
-18.2 % of myocardial shortening
Standard Deviation 3.0
|
|
Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)
LVGLS Change
|
-0.8 % of myocardial shortening
Standard Deviation 2.3
|
-0.3 % of myocardial shortening
Standard Deviation 3.3
|
0.2 % of myocardial shortening
Standard Deviation 2.7
|
-0.7 % of myocardial shortening
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 0 - 40 WeeksThe number of participants who had serum potassium \>6.5 mEq/L or serious hyperkalemia was assessed by treatment arm.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 Participants
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 Participants
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia
|
13 Participants
|
5 Participants
|
5 Participants
|
10 Participants
|
Adverse Events
Placebo
Serious events: 27 serious events
Other events: 45 other events
Deaths: 2 deaths
Spironolactone 12.5 mg
Serious events: 13 serious events
Other events: 24 other events
Deaths: 0 deaths
Spironolactone 25 mg
Serious events: 13 serious events
Other events: 25 other events
Deaths: 2 deaths
Spironolactone 50 mg
Serious events: 12 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 participants at risk
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 participants at risk
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 participants at risk
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Acute MI, atrial fibrillation, bradycardia, palpitations
|
0.00%
0/51 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.4%
2/27 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.7%
2/26 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Gastrointestinal disorders
Abdominal pain, diarrhea, GI hemorrhage, nausea, vomiting
|
13.7%
7/51 • Number of events 19 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.4%
2/27 • Number of events 8 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
19.2%
5/26 • Number of events 8 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
General disorders
Asthenia, chest pain
|
11.8%
6/51 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
23.1%
6/26 • Number of events 10 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Hepatobiliary disorders
Hemobilia, hepatic cirrhosis
|
2.0%
1/51 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Infections and infestations
Bacteremia, influenza, osteomyelitis, pneumonia. sepsis, skin graft infection, UTI, viral infection
|
7.8%
4/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
23.1%
6/26 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
20.0%
5/25 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Injury, poisoning and procedural complications
AVfistula site hemorrhage, vascular access complications, fall, laceration, rib fracture
|
11.8%
6/51 • Number of events 10 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
18.5%
5/27 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
19.2%
5/26 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Investigations
Cardiac catheterisation, fistulogram, pleural biopsy
|
7.8%
4/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Metabolism and nutrition disorders
Hyperkalemia, hypocalcemia, fluid overload
|
11.8%
6/51 • Number of events 8 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
24.0%
6/25 • Number of events 14 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia, back pain, neck pain, extremity pain
|
11.8%
6/51 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer, renal cell carcinoma
|
0.00%
0/51 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Nervous system disorders
Balance disorder, dementia, headache, paralysis, syncope
|
5.9%
3/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Psychiatric disorders
Anxiety, depression, mental status changes
|
2.0%
1/51 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Renal and urinary disorders
Bladder mass, hematuria, urinary retention
|
5.9%
3/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma, COPD, cough , dyspnea, pleural effusion, stridor
|
9.8%
5/51 • Number of events 9 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
14.8%
4/27 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
19.2%
5/26 • Number of events 13 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Skin and subcutaneous tissue disorders
Blister, erythema, pruritus
|
2.0%
1/51 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Surgical and medical procedures
Angioplasty, catheter placement, toe amputation, renal transplant, thrombectomy, nephrectomy
|
11.8%
6/51 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.5%
3/26 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
20.0%
5/25 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Vascular disorders
Hypertension, hypotension, thrombosis
|
3.9%
2/51 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
18.5%
5/27 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
16.0%
4/25 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants will be treated with placebo for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 12.5 mg
n=27 participants at risk
Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 25 mg
n=26 participants at risk
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
Spironolactone 50 mg
n=25 participants at risk
Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Spironolactone: The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/51 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/51 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/51 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Endocrine disorders
Hyperparathyroidism
|
7.8%
4/51 • Number of events 8 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
14.8%
4/27 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
23.1%
6/26 • Number of events 13 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
24.0%
6/25 • Number of events 11 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Eye disorders
Blurred vision
|
2.0%
1/51 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Gastrointestinal disorders
Abdominal pain, nausea, diarrhea, constipation
|
23.5%
12/51 • Number of events 23 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
37.0%
10/27 • Number of events 16 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
26.9%
7/26 • Number of events 21 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
24.0%
6/25 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
General disorders
Pain, peripheral edema, malaise
|
15.7%
8/51 • Number of events 10 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.5%
3/26 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Infections and infestations
Bronchitis, diverticulitis, cystitis, cellulitis, naspharyngitis
|
13.7%
7/51 • Number of events 11 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
14.8%
4/27 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
19.2%
5/26 • Number of events 6 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
16.0%
4/25 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Injury, poisoning and procedural complications
Fall, rib fracture, vascular graft complication
|
3.9%
2/51 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.4%
2/27 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
12.0%
3/25 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Investigations
Skin biopsy, liver biopsy, low hemoglobin
|
5.9%
3/51 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Metabolism and nutrition disorders
Hyperkalemia, hyperphosphatemia, hypercalcemia, gout
|
43.1%
22/51 • Number of events 70 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
37.0%
10/27 • Number of events 26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
42.3%
11/26 • Number of events 34 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
40.0%
10/25 • Number of events 39 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia, arthritis, osteoarthritis, tendonitis, neck pain
|
11.8%
6/51 • Number of events 12 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
15.4%
4/26 • Number of events 4 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
16.0%
4/25 • Number of events 10 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Nervous system disorders
Dizziness, headache, migraine, tremor, syncope
|
7.8%
4/51 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.4%
2/27 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
19.2%
5/26 • Number of events 9 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Renal and urinary disorders
Dysuria, hematuria, incontinence
|
5.9%
3/51 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/27 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/25 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Reproductive system and breast disorders
Breast tenderness, enlargement
|
3.9%
2/51 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Respiratory, thoracic and mediastinal disorders
COPD, pleural effusion, asthma, cough, dyspnea
|
5.9%
3/51 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
11.1%
3/27 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
7.7%
2/26 • Number of events 3 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Skin and subcutaneous tissue disorders
Pruritis, rash
|
7.8%
4/51 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.7%
1/27 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
8.0%
2/25 • Number of events 2 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Surgical and medical procedures
AV fistula, thrombectomy, catheter placement, stent placment, amputation, vascular operation
|
5.9%
3/51 • Number of events 7 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
14.8%
4/27 • Number of events 5 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
0.00%
0/26 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
4.0%
1/25 • Number of events 1 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
|
Vascular disorders
Hypotension
|
49.0%
25/51 • Number of events 90 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
51.9%
14/27 • Number of events 30 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
50.0%
13/26 • Number of events 46 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
68.0%
17/25 • Number of events 75 • Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.
Specific signs and symptoms, anticipated in patients treated with spironolactone, were collected on the Adverse Event of Interest form. Adverse events are reported according to the MedDRA hierarchy. The System Organ Class is comprised of a variety of related High Level Group Terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place