drugset / Trial / NCT05005793
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Phase 4
Recruiting
120 enrolled
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 0.5 unknown | Oral |