RecruitingPhase 1Phase 2NCT05687058

Empagliflozin in ESKD - A Feasibility Study


Sponsor

University of Mississippi Medical Center

Enrollment

24 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether empagliflozin — a drug commonly used for diabetes and heart failure — is safe and feasible to use in people who have end-stage kidney disease and are on dialysis. **You may be eligible if...** - You are 18 or older - You have end-stage kidney disease and are currently on dialysis (either hemodialysis or peritoneal dialysis) - You are able to give informed consent **You may NOT be eligible if...** - Your blood pressure is very low (systolic below 100 mmHg before dialysis) - You have had 2 or more urinary tract infections in the past year - You have a history of urinary retention or urinary obstruction - You have liver cirrhosis - You have advanced heart failure requiring a heart assist device - You have had a heart or liver transplant - You have active cancer - You are pregnant or breastfeeding - You have had ketoacidosis in the past 12 months - You have a known allergy to SGLT2 inhibitor medications 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 25 mg thrice-weekly post-hemodialysis dosing

Participants in Group I will be asked to take empagliflozin 25 mg after each hemodialysis session at home.

DRUGEmpagliflozin 10 mg daily dosing

Participants assigned to Group II will be asked to take empagliflozin 10 mg each morning between 8:30 and 9:30 a.m. at home.


Locations(2)

University of Mississippi Medical Center

Jackson, Mississippi, United States

Jackson Medicall Mall Dialysis Clinic

Jackson, Mississippi, United States

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NCT05687058


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