Study of Sodium Bicarbonate in Kidney Transplant Recipients
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Randomized Trial of Sodium Bicarbonate in Renal Transplant Recipients With Low-normal Serum Bicarbonate Levels|
- Urinary transforming growth factor-beta1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]This is considered a surrogate marker of chronic allograft nephropathy (tubulointerstitial fibrosis).
- urinary ammonia excretion [ Time Frame: 6 months ] [ Designated as safety issue: No ]a component of urinary acid excretion
|Study Start Date:||November 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Sodium bicarbonate
This group will receive oral sodium bicarbonate 650mg three times daily for 6 months.
Drug: Sodium bicarbonate
Sodium bicarbonate 650mg by mouth three times daily for 6 months.
No Intervention: Control
This group will not receive any sodium bicarbonate.
Renal allograft survival ten years after transplant is only about 50%. In people with non-transplant chronic kidney disease (CKD), sodium bicarbonate treatment seems to delay progressive decline in kidney function in those with low serum bicarbonate levels (metabolic acidosis). This may be because sodium bicarbonate reduces renal ammonia production and hence fibrosis. Observational evidence suggests that people with CKD and low-normal serum bicarbonate levels might also benefit from sodium bicarbonate treatment. TGF-beta1 levels seem to be an important predictor of chronic allograft nephropathy, and alkalinizing agents may have an effect on TFG-beta1 excretion.
Retrospective analysis of participants in the African American Study of Kidney Disease and Hypertension showed the lowest risk of CKD progression was among those having baseline serum bicarbonate levels in the range of 28-30 mmol/L. Recent studies in people with pre-transplant CKD have suggested that increasing low serum bicarbonate levels (< 22 mmol/L) with alkalinizing agents such as sodium bicarbonate and sodium citrate may reduce CKD progression.
Design: this is an open-label randomized study testing the effect of a six-month intervention with sodium bicarbonate 650 mg orally thrice daily versus no sodium bicarbonate treatment on renal ammonia excretion and urinary TGF-beta1.
Visits will occur at baseline, 3 months, and 6 months. At each follow-up visit, the study coordinator or principal investigator will review a medical questionnaire with the participant and collect a sample of blood and urine for analysis of urinary TGF-beta1, metabolic panel, pH, urinary net acid excretion, urinary bicarbonate and urinary ammonia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225796
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Kalani L Raphael, MD||University of Utah|