Empagliflozin in ESKD - A Feasibility Study

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 your condition) and will be followed up until one (1) month after the last dose. We will collect information about your 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Mississippi Medical Center
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin

Criteria

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 assessment)

8. major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)

9. active cancer

10. pregnant or lactating women

11. known allergy or hypersensitivity to any SGLT2 inhibitors

12. history of ketoacidosis during the last 12 months

13. any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).