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Empagliflozin in ESKD - A Feasibility Study
Sponsor: University of Mississippi Medical Center
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
Conditions
Interventions
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.
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