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Empagliflozin Treatment in Kidney Transplant Recipients
Sponsor: VA Office of Research and Development
Summary
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.
Official title: An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2024-04-05
Completion Date
2030-03-31
Last Updated
2025-05-04
Healthy Volunteers
No
Conditions
Interventions
Empagliflozin
SGLT2 Inhibitor
Locations (5)
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States