Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.
Chronic Renal Insufficiency
Drug: Sodium bicarbonate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Investigations of the Optimum Serum Bicarbonate Level in Renal Disease|
- Change in urinary transforming growth factor beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value. ] [ Designated as safety issue: No ]Urinary TGF-b1 is considered a marker of renal fibrosis
- Change in urinary Bb and membrane attack complex (MAC) [ Time Frame: The mean of the 3-month and 6-month urinary Bb and MAC measurements will be compared to the baseline values. ] [ Designated as safety issue: No ]These are biomarkers of renal complement system activation
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Arm 1
Drug: 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 Comparator: Arm 2
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.
Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574157
|Contact: Kalani L Raphael, MD||(801) 582-1565 ext 1234||Kalani.Raphael@va.gov|
|United States, Utah|
|VA Salt Lake City Health Care System, Salt Lake City, UT||Recruiting|
|Salt Lake City, Utah, United States, 84148|
|Contact: Kalani L Raphael, MD 801-582-1565 ext 1234 Kalani.Raphael@va.gov|
|Principal Investigator: Kalani L Raphael, MD|
|Principal Investigator:||Kalani L Raphael, MD||VA Salt Lake City Health Care System, Salt Lake City, UT|