Empagliflozin in ESKD - A Feasibility Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age ≥18 years;

• diagnosis of end-stage kidney disease requiring dialysis, and

• ability to provide informed consent.

Locations
United States
Mississippi
Jackson Medicall Mall Dialysis Clinic
RECRUITING
Jackson
University of Mississippi Medical Center
RECRUITING
Jackson
Contact Information
Primary
Yoshitsugu Obi, MD, PhD
yobi@umc.edu
601-984-5670
Backup
Rachael Thompson
rthompson3@umc.edu
(601)496-7822
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 24
Treatments
Experimental: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing
All participants undergoing thrice-weekly hemodialysis (HD) on the Monday-Wednesday-Friday (MWF) schedule will be assigned to the empagliflozin 25 mg thrice-weekly post-hemodialysis dosing arm (Group I).
Experimental: Empagliflozin 10 mg daily dosing
Patients undergoing thrice-weekly hemodialysis (HD) on the Tuesday-Thursday-Saturday (TTS) schedule, patients on twice-weekly HD, or patients on peritoneal dialysis will receive empagliflozin 10 mg daily (Group II).
Sponsors
Leads: University of Mississippi Medical Center

This content was sourced from clinicaltrials.gov