Empagliflozin in ESKD - A Feasibility Study
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.
Description
The incidence of end-stage kidney disease (ESKD) in the US ranks among the highest in the world. ESKD is the last phase of chronic kidney disease when the kidneys are functioning below 10-15% of normal capacity, and the patient is on dialysis. According to the US Renal Data System (USRDS), 120,834 individuals started dialysis and nearly 524,000 people were living on dialysis in 2017.1 Although advancement in technology and general medical care has led to a modest decrease in mortality among dialysis patients, their mortality rate remains extremely high at approximately 16.5 per 100 patient-yea…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. age ≥18 years; 2. diagnosis of end-stage kidney disease requiring dialysis, and 3. ability to provide informed consent. Exclusion Criteria: 1. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients) 2. two or more episodes of urinary tract infection within the last 12 months 3. history of urinary retention or urinary tract obstruction 4. liver cirrhosis 5. advanced heart failure requiring heart assist device or inotropic support 6. heart or liver transplant recipient 7. major surgery performed within the last 3 months ("major" per the investigator's assessm…
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 CenterJackson, Mississippi
- Jackson Medicall Mall Dialysis ClinicJackson, Mississippi