Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Start Date
3/1/2023
Completion Date
12/31/2026
Summary
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
Detailed Description
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks. At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug. At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Empagliflozin 25 mg vs Placebo
Empagliflozin 10 MG
Conditions
Locations
Yale University
New Haven, Connecticut 06510
United States