Trial Outcomes & Findings for Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis (NCT NCT01764854)
NCT ID: NCT01764854
Last Updated: 2020-08-10
Results Overview
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)
Results posted on
2020-08-10
Participant Flow
Participant milestones
| Measure |
AZD1722- in Patient
Tenapanor administered in a clinical pharmacology unit
AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
|
Placebo- in Patient
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
|
AZD1722 Out-patient
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
37
|
35
|
|
Overall Study
COMPLETED
|
8
|
8
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
6
|
2
|
Reasons for withdrawal
| Measure |
AZD1722- in Patient
Tenapanor administered in a clinical pharmacology unit
AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
|
Placebo- in Patient
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
|
AZD1722 Out-patient
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
relocation
|
0
|
0
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
Baseline characteristics by cohort
| Measure |
AZD1722- in Patient
n=8 Participants
Tenapanor administered in a clinical pharmacology unit
AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
|
Placebo- in Patient
n=8 Participants
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
Placebo (in-patient): Placebo, size and color matched to experimental drug administered in a CPU
|
AZD1722 Out-patient
n=37 Participants
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
n=35 Participants
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 8.3 • n=39 Participants
|
54.4 years
STANDARD_DEVIATION 6.5 • n=41 Participants
|
51.5 years
STANDARD_DEVIATION 11.5 • n=35 Participants
|
49.3 years
STANDARD_DEVIATION 11.8 • n=31 Participants
|
50.6 years
STANDARD_DEVIATION 11.6 • n=146 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
33 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
55 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
25 Participants
n=31 Participants
|
64 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Height
|
172.89 centimeters
STANDARD_DEVIATION 9.31 • n=39 Participants
|
172.05 centimeters
STANDARD_DEVIATION 16.48 • n=41 Participants
|
170.23 centimeters
STANDARD_DEVIATION 10.80 • n=35 Participants
|
170.20 centimeters
STANDARD_DEVIATION 10.39 • n=31 Participants
|
170.63 centimeters
STANDARD_DEVIATION 10.84 • n=146 Participants
|
PRIMARY outcome
Timeframe: Run-in period (Weeks -2 and -1) versus Week 4 (end of treatment)Population: The out-patient arms were the only groups that were pre-specified to be included in this analysis since the in-patient arms were only treated for one week.
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
Outcome measures
| Measure |
AZD1722 Out-patient
n=37 Participants
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
n=35 Participants
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|
|
Change in Mean Weekly Interdialytic Weight Gain (IDWG)
|
-0.26 kilograms
Standard Deviation 0.939
|
-0.23 kilograms
Standard Deviation 0.871
|
SECONDARY outcome
Timeframe: Days 1 through 7Population: The in-patient arms were the only groups pre-specified to be used in this analysis since stool could only be collected in the clinical pharmacology unit (in-patient).
The amount of sodium in a days worth of stool output
Outcome measures
| Measure |
AZD1722 Out-patient
n=8 Participants
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
n=8 Participants
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|
|
Stool Sodium Content
|
36.62 mEq/day
Standard Deviation 21.809
|
2.82 mEq/day
Standard Deviation 2.655
|
Adverse Events
AZD1722- in Patient
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo- in Patient
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
AZD1722 Out-patient
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Out-patient
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD1722- in Patient
n=8 participants at risk
Tenapanor administered in a clinical pharmacology unit
AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
|
Placebo- in Patient
n=8 participants at risk
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
|
AZD1722 Out-patient
n=37 participants at risk
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
n=35 participants at risk
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|---|---|
|
Cardiac disorders
Syncope
|
0.00%
0/8 • one month
|
12.5%
1/8 • Number of events 1 • one month
|
2.7%
1/37 • Number of events 1 • one month
|
0.00%
0/35 • one month
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/8 • one month
|
0.00%
0/8 • one month
|
2.7%
1/37 • Number of events 1 • one month
|
0.00%
0/35 • one month
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/8 • one month
|
12.5%
1/8 • Number of events 1 • one month
|
0.00%
0/37 • one month
|
0.00%
0/35 • one month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
local swelling
|
0.00%
0/8 • one month
|
12.5%
1/8 • Number of events 1 • one month
|
0.00%
0/37 • one month
|
0.00%
0/35 • one month
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/8 • one month
|
0.00%
0/8 • one month
|
0.00%
0/37 • one month
|
2.9%
1/35 • Number of events 1 • one month
|
Other adverse events
| Measure |
AZD1722- in Patient
n=8 participants at risk
Tenapanor administered in a clinical pharmacology unit
AZD1722 (in-patient): doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
|
Placebo- in Patient
n=8 participants at risk
Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit
|
AZD1722 Out-patient
n=37 participants at risk
Tenapanor
AZD1722 (out-patient): doses between 5 and 45 mg BID
|
Placebo Out-patient
n=35 participants at risk
Placebo
Placebo: Placebo, size and color matched to experimental drug
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
75.0%
6/8 • Number of events 6 • one month
|
25.0%
2/8 • Number of events 2 • one month
|
8.1%
3/37 • Number of events 3 • one month
|
60.0%
21/35 • Number of events 21 • one month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60