Actively Recruiting
Empagliflozin in ESKD - A Feasibility Study
Led by University of Mississippi Medical Center · Updated on 2025-06-25
24
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Empagliflozin in ESKD - A Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of end-stage kidney disease requiring dialysis
- Ability to provide informed consent
You will not qualify if you...
- Systolic blood pressure below 100 mm Hg before dialysis (for hemodialysis patients)
- Two or more urinary tract infections within the last 12 months
- History of urinary retention or urinary tract obstruction
- Liver cirrhosis
- Advanced heart failure requiring heart assist device or inotropic support
- Heart or liver transplant recipient
- Major surgery within the last 3 months or planned within 3 months after screening
- Active cancer
- Pregnant or lactating women
- Known allergy or hypersensitivity to any SGLT2 inhibitors
- History of ketoacidosis in the last 12 months
- Any other medical condition deemed inappropriate by nephrologists or study physician, such as cachexia, short life expectancy, or uncontrolled psychological disorder
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Trial Site Locations
Total: 2 locations
1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39157
Actively Recruiting
2
Jackson Medicall Mall Dialysis Clinic
Jackson, Mississippi, United States, 39213
Actively Recruiting
Research Team
Y
Yoshitsugu Obi, MD, PhD
CONTACT
R
Rachael Thompson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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