RecruitingPhase 4NCT06013865

Empagliflozin Treatment in Kidney Transplant Recipients

An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)


Sponsor

VA Office of Research and Development

Enrollment

264 participants

Start Date

Apr 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing empagliflozin (a diabetes and kidney protection drug, sometimes called an SGLT2 inhibitor) in kidney transplant recipients to see if it can slow kidney decline and protect the transplanted kidney over time. **You may be eligible if...** - You are over 18 and received a kidney transplant at least 3 months ago - Your transplanted kidney is showing signs of reduced function (specific eGFR and protein/creatinine levels) - You have diabetes or high protein spilling into your urine that puts the kidney at risk **You may NOT be eligible if...** - You have previously had a pancreas transplant - Your kidney function is critically low (eGFR below 20 or 30 depending on diabetes status) - Your diabetes is very poorly controlled (HbA1c above 12%) - You have had frequent urinary tract infections, urosepsis, or require a urinary catheter - You have used an SGLT2 inhibitor in the past 90 days or are allergic to one - You have Type 1 diabetes or a history of diabetic ketoacidosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin

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

View Full Details on ClinicalTrials.gov

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NCT06013865


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