Clinical Trial

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

Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-11-14; most recent amendment 2025-05-28.
Status change: Not Yet Recruiting → Recruiting 2024-02-15
Trial Details
NCT Number NCT06140537
Lead Sponsor University of Colorado, Denver
Conditions Kidney Transplant; Complications, Vascular Diseases, Diabetes
Enrollment 80 participants
Start Date 2024-02-01
Primary Completion 2028-10-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-05-29