Trial Outcomes & Findings for Investigations of the Optimum Serum Bicarbonate Level in Renal Disease. (NCT NCT01574157)
NCT ID: NCT01574157
Last Updated: 2019-08-28
Results Overview
Urinary TGF-b1 is considered a marker of renal fibrosis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Results posted on
2019-08-28
Participant Flow
Participants were recruited from VA Salt Lake City Healthcare System from November 2012 to October 2017.
Participant milestones
| Measure |
Sodium Bicarbonate
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
|
Placebo
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
39
|
|
Overall Study
Month 3
|
31
|
33
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
| Measure |
Sodium Bicarbonate
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months.
|
Placebo
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate
n=35 Participants
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 8 • n=99 Participants
|
73 years
STANDARD_DEVIATION 8 • n=107 Participants
|
72 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 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
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
68 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
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Estimated glomerular filtration rate
|
50 ml/min/1.73m2
STANDARD_DEVIATION 20 • n=99 Participants
|
52 ml/min/1.73m2
STANDARD_DEVIATION 16 • n=107 Participants
|
51 ml/min/1.73m2
STANDARD_DEVIATION 18 • n=206 Participants
|
|
Systolic blood pressure
|
129 mm Hg
STANDARD_DEVIATION 12 • n=99 Participants
|
127 mm Hg
STANDARD_DEVIATION 11 • n=107 Participants
|
128 mm Hg
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Use of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Total body weight
|
100 kg
STANDARD_DEVIATION 18 • n=99 Participants
|
101 kg
STANDARD_DEVIATION 22 • n=107 Participants
|
101 kg
STANDARD_DEVIATION 20 • n=206 Participants
|
|
Lean body weight
|
67 kg
STANDARD_DEVIATION 8 • n=99 Participants
|
68 kg
STANDARD_DEVIATION 9 • n=107 Participants
|
68 kg
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Congestive heart failure
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Serum total carbon dioxide (CO2)
|
24 meq/L
STANDARD_DEVIATION 3 • n=99 Participants
|
24 meq/L
STANDARD_DEVIATION 2 • n=107 Participants
|
24 meq/L
STANDARD_DEVIATION 2 • n=206 Participants
|
|
Serum potassium
|
4.2 meq/L
STANDARD_DEVIATION 0.4 • n=99 Participants
|
4.3 meq/L
STANDARD_DEVIATION 0.4 • n=107 Participants
|
4.2 meq/L
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Hemoglobin A1c
|
7.5 %
STANDARD_DEVIATION 1.0 • n=99 Participants
|
7.6 %
STANDARD_DEVIATION 1.3 • n=107 Participants
|
7.5 %
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Urinary albumin/creatinine
|
121 mg/g
n=99 Participants
|
131 mg/g
n=107 Participants
|
121 mg/g
n=206 Participants
|
|
Urinary pH
|
5.6 units on a scale
STANDARD_DEVIATION 0.4 • n=99 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 0.4 • n=107 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Urinary ammonium
|
36 meq/d
STANDARD_DEVIATION 18 • n=99 Participants
|
33 meq/d
STANDARD_DEVIATION 21 • n=107 Participants
|
34 meq/d
STANDARD_DEVIATION 20 • n=206 Participants
|
|
Urinary titratable acids
|
32 meq/d
STANDARD_DEVIATION 14 • n=99 Participants
|
31 meq/d
STANDARD_DEVIATION 16 • n=107 Participants
|
32 meq/d
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Urinary transforming growth factor-B1/creatinine
|
122 ng/g
n=99 Participants
|
103 ng/g
n=107 Participants
|
112 ng/g
n=206 Participants
|
|
Urinary kidney injury molecule-1/creatinine
|
0.91 ng/mg
n=99 Participants
|
0.88 ng/mg
n=107 Participants
|
0.89 ng/mg
n=206 Participants
|
|
Urinary fibronectin/creatinine
|
107 ng/mg
n=99 Participants
|
97 ng/mg
n=107 Participants
|
102 ng/mg
n=206 Participants
|
|
Urinary neutrophil gelatinase-associated lipocalin/creatinine
|
10.5 ng/mg
n=99 Participants
|
11.9 ng/mg
n=107 Participants
|
11.1 ng/mg
n=206 Participants
|
PRIMARY outcome
Timeframe: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.Urinary TGF-b1 is considered a marker of renal fibrosis
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
|
7.6 percent change
Interval -9.6 to 28.0
|
-4.4 percent change
Interval -19.4 to 13.4
|
SECONDARY outcome
Timeframe: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.KIM-1 is a marker of of kidney injury.
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
|
-11.4 percent change
Interval -33.0 to 17.0
|
-1.5 percent change
Interval -24.9 to 29.2
|
SECONDARY outcome
Timeframe: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.NGAL is a marker of kidney injury
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
|
-28.5 percent change
Interval -48.7 to -0.3
|
5.9 percent change
Interval -23.9 to 47.6
|
SECONDARY outcome
Timeframe: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.Fibronectin is a marker of kidney injury.
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Urinary Levels of Fibronectin
|
8.8 percent change
Interval -9.4 to 30.7
|
1.1 percent change
Interval -15.8 to 21.3
|
SECONDARY outcome
Timeframe: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.Urinary albumin is a marker of kidney damage
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Urinary Albumin Levels
|
21.1 percent change
Interval -3.1 to 51.3
|
11.9 percent change
Interval -10.5 to 39.8
|
SECONDARY outcome
Timeframe: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.eGFR is a measure of kidney function
Outcome measures
| Measure |
Sodium Bicarbonate
n=35 Participants
Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
Sodium bicarbonate: Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
|
Placebo
n=39 Participants
Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
Placebo: Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
|
|---|---|---|
|
Change in Estimated Glomerular Filtration (eGFR)
|
1.96 ml/min per 1.73m2
Interval -0.47 to 4.4
|
-1.41 ml/min per 1.73m2
Interval -3.8 to 0.99
|
Adverse Events
Sodium Bicarbonate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kalani Raphael, Principal Investigator
VA Salt Lake City Healthcare System
Phone: 801-582-1565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place