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RECRUITING
NCT06013865
PHASE4

Empagliflozin Treatment in Kidney Transplant Recipients

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

DRUG

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