drugset / Trial / NCT06140537

Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

NCT06140537 ↗

Phase 4 Recruiting 80 enrolled University of Colorado, Denver
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.

Timeline

Start
2024-02-01
Primary completion
2028-10-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral