drugset / Trial / NCT05005793

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

NCT05005793

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-12-01
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium bicarbonate Diagnostic / imaging agent 0.5 unknown Oral