Clinical Trial

Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

Recruiting Phase 4
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-08-10; most recent amendment 2025-05-28.
Status change: Not Yet Recruiting → Recruiting 2021-12-10
Trial Details
NCT Number NCT05005793
Lead Sponsor University of Colorado, Denver
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Metabolic Acidosis, Kidney Transplant; Complications, Vascular Diseases
Enrollment 120 participants
Start Date 2021-12-01
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29