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RECRUITING
NCT05687058
PHASE1/PHASE2

Empagliflozin in ESKD - A Feasibility Study

Sponsor: University of Mississippi Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-11-01

Completion Date

2025-12-31

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DRUG

Empagliflozin 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.

DRUG

Empagliflozin 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