Trial Outcomes & Findings for Alkali Therapy in Chronic Kidney Disease (NCT NCT01452412)
NCT ID: NCT01452412
Last Updated: 2020-01-07
Results Overview
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
149 participants
Primary outcome timeframe
2 year
Results posted on
2020-01-07
Participant Flow
Participant milestones
| Measure |
Sodium Bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
46
|
58
|
|
Overall Study
NOT COMPLETED
|
28
|
17
|
Reasons for withdrawal
| Measure |
Sodium Bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
11
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Initiated dialysis
|
1
|
0
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Alkali Therapy in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
61.6 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
61 years
STANDARD_DEVIATION 12.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Serum bicarbonate
|
24 mEq/L
STANDARD_DEVIATION 2.2 • n=99 Participants
|
24.1 mEq/L
STANDARD_DEVIATION 2.6 • n=107 Participants
|
24 mEq/L
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
estimated glomerular filtration rate (eGFR)
|
36.2 ml/min/1.73m2
STANDARD_DEVIATION 11.1 • n=99 Participants
|
36.4 ml/min/1.73m2
STANDARD_DEVIATION 11.4 • n=107 Participants
|
36.3 ml/min/1.73m2
STANDARD_DEVIATION 11.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearSit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
Outcome measures
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
|
23.8 seconds
Standard Deviation 5.8
|
22.9 seconds
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: 2 yearThe investigators will evaluate changes in bone mineral density at the wrist.
Outcome measures
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
DEXA of Wrist
|
0.75 g/cm2
Standard Deviation 0.23
|
0.73 g/cm2
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 2 yearHand-grip strength will be measured in all participants
Outcome measures
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Hand-grip Strength
|
27.3 kg
Standard Deviation 9.8
|
24.9 kg
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: 2 yearEstimated GFR
Outcome measures
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Estimated GFR
|
38.5 ml/min/1.73m2
Standard Deviation 17.7
|
36.3 ml/min/1.73m2
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 2 yearShort Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning.
Outcome measures
| Measure |
Sodium Bicarbonate
n=74 Participants
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 Participants
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Quality of Life - Physical Function Domain
|
40 score on a scale
Standard Deviation 12
|
43 score on a scale
Standard Deviation 11
|
Adverse Events
Sodium Bicarbonate
Serious events: 20 serious events
Other events: 29 other events
Deaths: 1 deaths
Placebo
Serious events: 15 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Bicarbonate
n=74 participants at risk
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 participants at risk
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
General disorders
All-cause hospitalization
|
27.0%
20/74 • Number of events 20
|
20.0%
15/75 • Number of events 15
|
Other adverse events
| Measure |
Sodium Bicarbonate
n=74 participants at risk
0.4 mEq/kg/day ideal body weight to be taken once a day
Sodium bicarbonate: 0.4 mEq/kg/day ideal body weight to be taken once a day
|
Placebo
n=75 participants at risk
placebo dosage/frequency equivalent to sodium bicarbonate
Placebo: To be taken on the same schedule as the active arm
|
|---|---|---|
|
Renal and urinary disorders
Serum bicarbonate >=30
|
12.2%
9/74 • Number of events 9
|
6.7%
5/75 • Number of events 5
|
|
Renal and urinary disorders
Serum bicarbonate <=18
|
2.7%
2/74 • Number of events 2
|
5.3%
4/75 • Number of events 4
|
|
Renal and urinary disorders
Serum potassium <=3.5
|
5.4%
4/74 • Number of events 4
|
2.7%
2/75 • Number of events 2
|
|
Renal and urinary disorders
Serum potassium >= 5.0 mEq/L
|
18.9%
14/74 • Number of events 14
|
40.0%
30/75 • Number of events 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place