NCT05671991

Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
DRUG	Empagliflozin 25 mg vs Placebo	Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
DRUG	Empagliflozin 10 MG	Chronic Study- Empagliflozin 10 mg for 8 weeks

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2023-01-05
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study