Study of Sodium Bicarbonate Treatment to Improve Blood Vessel and Kidney Graft Function in Adults with Kidney Transplants

What this Trial Is About

Researchers are evaluating the effects of alkali therapy on kidney transplant recipients KTRs who often have lower serum bicarbonate levels within the normal range. This condition is linked to higher risks of graft loss, cardiovascular events, and mortality. The study aims to determine whether sodium bicarbonate treatment can improve vascular and graft function by reducing complement activation in these patients. The trial is a randomized, double-blinded, placebo-controlled study lasting 12 months, involving 120 KTRs. Participants will receive either oral sodium bicarbonate or a placebo at a dose of 0.5 mEq per kg of lean body weight per day. The study compares these two groups to assess changes in vascular and kidney graft function over time. Participants will be closely monitored at baseline and after 12 months with tests including brachial artery flow-mediated dilation, artery stiffness and compliance, tubular atrophy, plasma and urine complement activation fragments, and interstitial fibrosis. The study will track these markers to evaluate treatment effects, with safety and adherence monitored throughout. The total duration for each participant is one year.

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