Empagliflozin Treatment in Kidney Transplant Recipients

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.

NCT Number	NCT06013865
Lead Sponsor	VA Office of Research and Development Collaborators: Iowa City VA Health Care System, VA Pittsburgh Healthcare System, VA Tennessee Valley Health Care System, VA Hines Health Care
Conditions	Kidney Transplant, Chronic Kidney Disease
Enrollment	264 participants
Start Date	2024-04-05
Primary Completion	2030-03-31 (estimated)
Study Completion	2030-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-21