Safety and Effects of Empagliflozin in Adults with Kidney Transplants and Chronic Kidney Disease

What this Trial Is About

Researchers are investigating the use of empagliflozin, a type of SGLT2 inhibitor, in Veterans who have received kidney transplants and have chronic kidney disease CKD, with or without type 2 diabetes mellitus T2DM. Although kidney transplantation improves health and quality of life, long-term outcomes remain challenging due to a high risk of cardiovascular disease and graft loss. Previous studies showed benefits of SGLT2 inhibitors in CKD patients but excluded kidney transplant recipients due to safety concerns. This trial aims to assess the safety and effects of empagliflozin in this specific population. This open-label clinical trial will treat eligible kidney transplant recipients with empagliflozin 12.5 mg once daily. The study is conducted at multiple VA medical centers with expertise in transplant and diabetes care. Researchers will closely monitor participants for adverse events and any effects on graft function or diabetes management. Data from non-treated kidney transplant recipients will be used for comparison to further evaluate cardiovascular outcomes, kidney disease progression, and healthcare costs associated with empagliflozin use. Participants will be followed for about two years, during which researchers will assess discontinuation of empagliflozin and monitor infections, hypoglycemia, major cardiac and kidney events, graft dysfunction, rejection episodes, and other safety concerns. Laboratory tests, kidney biopsies, and assessments of kidney function, blood sugar control, body weight, and blood pressure will also be performed. The study aims to provide important safety and feasibility data to improve care for kidney transplant recipients.

Empagliflozin Treatment in Kidney Transplant Recipients