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Empagliflozin Treatment in Kidney Transplant Recipients

NCT06013865 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Empagliflozin

SGLT2 Inhibitor

Sponsors & Collaborators

  • Iowa City VA Health Care System

    collaborator FED

  • VA Pittsburgh Healthcare System

    collaborator FED

  • VA Tennessee Valley Health Care System

    collaborator FED

  • VA Hines Health Care

    collaborator UNKNOWN

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Roslyn B Mannon, MD · Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2030-03-31
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013865 on ClinicalTrials.gov