Trial Outcomes & Findings for Bicarbonate Administration in CKD (NCT NCT02915601)
NCT ID: NCT02915601
Last Updated: 2023-07-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Measured at baseline and 12 months
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
Sodium Bicarbonate
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
44
|
46
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bicarbonate Administration in CKD
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate
n=55 Participants
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=54 Participants
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Sodium Bicarbonate
n=44 Participants
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=46 Participants
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Change in Brachial Artery Flow Mediated Dilation
Baseline
|
3.99 percentage
Standard Deviation 4.8
|
3.78 percentage
Standard Deviation 4.3
|
|
Change in Brachial Artery Flow Mediated Dilation
12 months
|
4.25 percentage
Standard Deviation 3.51
|
4.43 percentage
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: Measured at baseline,12 monthsOutcome measures
| Measure |
Sodium Bicarbonate
n=44 Participants
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=46 Participants
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Change in Aortic Pulse Wave Velocity
Baseline
|
998.3 cm/sec
Standard Deviation 447.5
|
994.8 cm/sec
Standard Deviation 373.5
|
|
Change in Aortic Pulse Wave Velocity
12 months
|
1067.2 cm/sec
Standard Deviation 457.9
|
983.4 cm/sec
Standard Deviation 347.7
|
SECONDARY outcome
Timeframe: Measured at baseline and 12 monthsOutcome measures
| Measure |
Sodium Bicarbonate
n=44 Participants
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=46 Participants
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Change in Left Ventricular Mass Index
Baseline
|
57.4 g/m2
Interval 51.5 to 67.9
|
59.4 g/m2
Interval 51.4 to 76.1
|
|
Change in Left Ventricular Mass Index
12 months
|
57.2 g/m2
Interval 53.1 to 66.8
|
67.6 g/m2
Interval 51.6 to 78.3
|
Adverse Events
Sodium Bicarbonate
Serious events: 7 serious events
Other events: 36 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 28 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sodium Bicarbonate
n=55 participants at risk
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=54 participants at risk
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Infections and infestations
Hospitalizations
|
1.8%
1/55 • Number of events 1 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Cardiac disorders
Hospitalizations
|
1.8%
1/55 • Number of events 1 • 12 months
|
3.7%
2/54 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Hospitalization
|
1.8%
1/55 • Number of events 1 • 12 months
|
3.7%
2/54 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Hospitalization
|
0.00%
0/55 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Endocrine disorders
Hospitalization
|
3.6%
2/55 • Number of events 2 • 12 months
|
0.00%
0/54 • 12 months
|
|
Vascular disorders
Hospitalization
|
1.8%
1/55 • Number of events 1 • 12 months
|
0.00%
0/54 • 12 months
|
|
Renal and urinary disorders
Initiation of dialysis
|
1.8%
1/55 • Number of events 1 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Sodium Bicarbonate
n=55 participants at risk
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Sodium bicarbonate
|
Placebo
n=54 participants at risk
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
Placebo
|
|---|---|---|
|
Cardiac disorders
Increase in diuretic therapy
|
14.5%
8/55 • Number of events 8 • 12 months
|
13.0%
7/54 • Number of events 7 • 12 months
|
|
Cardiac disorders
Increase in antihypertensive therapy
|
20.0%
11/55 • Number of events 11 • 12 months
|
22.2%
12/54 • Number of events 12 • 12 months
|
|
Renal and urinary disorders
High serum bicarbonate level >28 mEq/L
|
23.6%
13/55 • Number of events 13 • 12 months
|
1.9%
1/54 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Low serum bicarbonate level < 20 mEq/L
|
7.3%
4/55 • Number of events 4 • 12 months
|
14.8%
8/54 • Number of events 8 • 12 months
|
Additional Information
Dr. Jessica Kendrick
University of Colorado Anschutz Medical Campus
Phone: 3037244837
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place