About this trial
Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.
Eligibility criteria
Qualifiers
Age 18-80 years
Serum bicarbonate 16-24 mEq/L on 2 separate measurements (at least 1 day apart)
Kidney transplant received 1 year prior to randomization
eGFR ≥ 45 ml/min/1.73m2 by CKD-EPI equation
Disqualifiers
Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
Uncontrolled hypertension
Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
Trial design
Treatments tested in this trial
- Sodium bicarbonate
- Placebo
Treatment groups
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator