Trial Outcomes & Findings for The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (NCT NCT02521181)
NCT ID: NCT02521181
Last Updated: 2020-10-20
Results Overview
The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
Baseline, 28 weeks
Results posted on
2020-10-20
Participant Flow
Patients were recruited from the CKD medical clinic patients of the recruiting centers.
Participant milestones
| Measure |
Lower Dose Sodium Bicarbonate
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Higher Dose Sodium Bicarbonate
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
|---|---|---|---|
|
Overall Study
STARTED
|
52
|
90
|
52
|
|
Overall Study
COMPLETED
|
52
|
90
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)
Baseline characteristics by cohort
| Measure |
Lower Dose Sodium Bicarbonate
n=52 Participants
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Higher Dose Sodium Bicarbonate
n=90 Participants
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo
n=52 Participants
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
74 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
120 Participants
n=157 Participants
|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
67.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
66.6 years
STANDARD_DEVIATION 11.7 • n=157 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
63 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
131 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
177 Participants
n=157 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=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
67 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
109 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
90 participants
n=107 Participants
|
52 participants
n=206 Participants
|
194 participants
n=157 Participants
|
|
CKD Stage
Stage 3A (eGFR 45-60)
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
30 Participants
n=157 Participants
|
|
CKD Stage
Stage 3B (eGFR 30-45)
|
30 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
107 Participants
n=157 Participants
|
|
CKD Stage
Stage 4 (eGFR 15-30)
|
13 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
57 Participants
n=157 Participants
|
|
Diabetes Mellitus
|
27 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
105 Participants
n=157 Participants
|
|
History of Heart Disease
|
18 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
66 Participants
n=157 Participants
|
|
Congestive Heart Failure
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
|
COPD
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=157 Participants
|
|
Smoking Status
Never
|
26 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
98 Participants
n=157 Participants
|
|
Smoking Status
Former Smoker
|
15 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
79 Participants
n=157 Participants
|
|
Smoking Status
Current Smoker
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
17 Participants
n=157 Participants
|
|
Weight
|
96.1 kg
STANDARD_DEVIATION 25.8 • n=99 Participants
|
95.4 kg
STANDARD_DEVIATION 22.4 • n=107 Participants
|
93.6 kg
STANDARD_DEVIATION 20.3 • n=206 Participants
|
95.1 kg
STANDARD_DEVIATION 22.7 • n=157 Participants
|
|
BMI
|
32.8 kg/m^2
STANDARD_DEVIATION 8.43 • n=99 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 7.87 • n=107 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 5.92 • n=206 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 7.54 • n=157 Participants
|
|
Lean Body Mass
|
58.4 kg
STANDARD_DEVIATION 10.7 • n=99 Participants
|
58.4 kg
STANDARD_DEVIATION 9.84 • n=107 Participants
|
58.7 kg
STANDARD_DEVIATION 9.44 • n=206 Participants
|
58.5 kg
STANDARD_DEVIATION 9.91 • n=157 Participants
|
|
Systolic BP
|
127 mm Hg
STANDARD_DEVIATION 13.7 • n=99 Participants
|
127 mm Hg
STANDARD_DEVIATION 12.3 • n=107 Participants
|
127 mm Hg
STANDARD_DEVIATION 13.0 • n=206 Participants
|
127 mm Hg
STANDARD_DEVIATION 12.8 • n=157 Participants
|
|
Ace/ARB Use
|
40 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
135 Participants
n=157 Participants
|
|
eGFR
|
36.5 ml/min/1.73m^2
STANDARD_DEVIATION 9.56 • n=99 Participants
|
36.4 ml/min/1.73m^2
STANDARD_DEVIATION 9.60 • n=107 Participants
|
34.5 ml/min/1.73m^2
STANDARD_DEVIATION 8.59 • n=206 Participants
|
35.9 ml/min/1.73m^2
STANDARD_DEVIATION 9.32 • n=157 Participants
|
|
Urine Albumin / Creatinine Ratio
|
222 g/mg
n=99 Participants
|
176 g/mg
n=107 Participants
|
147 g/mg
n=206 Participants
|
181 g/mg
n=157 Participants
|
|
Serum Bicarbonate
|
24.2 meq/L
STANDARD_DEVIATION 2.25 • n=99 Participants
|
24.2 meq/L
STANDARD_DEVIATION 2.38 • n=107 Participants
|
23.8 meq/L
STANDARD_DEVIATION 2.17 • n=206 Participants
|
24.1 meq/L
STANDARD_DEVIATION 2.28 • n=157 Participants
|
|
Serum Potassium
|
4.5 meq/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
4.4 meq/L
STANDARD_DEVIATION 0.4 • n=107 Participants
|
4.5 meq/L
STANDARD_DEVIATION 0.5 • n=206 Participants
|
4.5 meq/L
STANDARD_DEVIATION 0.4 • n=157 Participants
|
|
Urinary Ammonium
|
19.3 mmol/day
STANDARD_DEVIATION 10.5 • n=99 Participants
|
22.0 mmol/day
STANDARD_DEVIATION 12.2 • n=107 Participants
|
20.5 mmol/day
STANDARD_DEVIATION 13.2 • n=206 Participants
|
20.9 mmol/day
STANDARD_DEVIATION 12.0 • n=157 Participants
|
|
Urinary PH
|
5.86 units on a scale
STANDARD_DEVIATION 0.46 • n=99 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 0.46 • n=107 Participants
|
5.81 units on a scale
STANDARD_DEVIATION 0.56 • n=206 Participants
|
5.80 units on a scale
STANDARD_DEVIATION 0.49 • n=157 Participants
|
|
Estimated DIetary Protein Intake
|
73.3 g/day
STANDARD_DEVIATION 25.4 • n=99 Participants
|
81.9 g/day
STANDARD_DEVIATION 30.5 • n=107 Participants
|
79.1 g/day
STANDARD_DEVIATION 29.5 • n=206 Participants
|
78.8 g/day
STANDARD_DEVIATION 29.0 • n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline, 28 weeksThe prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period. The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks. The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day.
Outcome measures
| Measure |
Lower Dose Sodium Bicarbonate
n=52 Participants
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Higher Dose Sodium Bicarbonate
n=90 Participants
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo
n=52 Participants
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
|---|---|---|---|
|
Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group
Number of Patients Completing on Full Dose
|
50 participants
|
78 participants
|
45 participants
|
|
Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group
Num of Patients Completing on >= 25% of Full Dose
|
51 participants
|
82 participants
|
48 participants
|
Adverse Events
Lower Dose Sodium Bicarbonate
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Higher Dose Sodium Bicarbonate
Serious events: 16 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 42 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Lower Dose Sodium Bicarbonate
n=52 participants at risk
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Higher Dose Sodium Bicarbonate
n=90 participants at risk
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo
n=52 participants at risk
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
|---|---|---|---|
|
Renal and urinary disorders
Reached ESRD (Dialysis or Transplant)
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Cardiac disorders
Cardiovascular Hospitalizations
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
3.3%
3/90 • Number of events 3 • 32 Weeks
|
3.8%
2/52 • Number of events 2 • 32 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal Hospitalizations
|
3.8%
2/52 • Number of events 2 • 32 Weeks
|
3.3%
3/90 • Number of events 3 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Injury, poisoning and procedural complications
Infection Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
1.9%
1/52 • Number of events 2 • 32 Weeks
|
|
Renal and urinary disorders
Renal Hospitalizations
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancy Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Injury, poisoning and procedural complications
Injury Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
0.00%
0/90 • 32 Weeks
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Hospitalizations
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
5.6%
5/90 • Number of events 5 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Endocrine disorders
Endocrine Disorder Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Vascular disorders
Vascular Hospitalizations
|
0.00%
0/52 • 32 Weeks
|
1.1%
1/90 • Number of events 1 • 32 Weeks
|
0.00%
0/52 • 32 Weeks
|
|
Psychiatric disorders
Psychiatric Hospitalizations
|
1.9%
1/52 • Number of events 2 • 32 Weeks
|
0.00%
0/90 • 32 Weeks
|
1.9%
1/52 • Number of events 1 • 32 Weeks
|
Other adverse events
| Measure |
Lower Dose Sodium Bicarbonate
n=52 participants at risk
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate. Half of the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Lower Dose Sodium Bicarbonate: Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Higher Dose Sodium Bicarbonate
n=90 participants at risk
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Higher Dose Sodium Bicarbonate: Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo
n=52 participants at risk
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate. Half the total daily dose is taken in the morning and the other half is taken in the evening. (If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
Placebo: Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
|---|---|---|---|
|
Gastrointestinal disorders
Severe gastrointestinal symptoms
|
17.3%
9/52 • Number of events 15 • 32 Weeks
|
17.8%
16/90 • Number of events 28 • 32 Weeks
|
9.6%
5/52 • Number of events 6 • 32 Weeks
|
|
Gastrointestinal disorders
Moderate gastrointestinal symptoms
|
13.5%
7/52 • Number of events 17 • 32 Weeks
|
24.4%
22/90 • Number of events 36 • 32 Weeks
|
25.0%
13/52 • Number of events 17 • 32 Weeks
|
|
Gastrointestinal disorders
Mild gastrointestinal symptoms
|
46.2%
24/52 • Number of events 54 • 32 Weeks
|
40.0%
36/90 • Number of events 107 • 32 Weeks
|
46.2%
24/52 • Number of events 62 • 32 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place