Clinical Trial

Empagliflozin in ESKD - A Feasibility Study

Active, Not Recruiting Phase 1/2
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Summary
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin. Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-01-12; most recent amendment 2026-05-19.
Status change: Recruiting → Active, Not Recruiting 2026-05-19
Status change: Not Yet Recruiting → Recruiting 2024-01-18
Trial Details
NCT Number NCT05687058
Lead Sponsor University of Mississippi Medical Center
Conditions Kidney Failure, Chronic, Heart Failure
Enrollment 24 participants
Start Date 2023-11-01
Primary Completion 2026-05-04 (estimated)
Study Completion 2026-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-05-22