Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients actively undergoing PD with a reliably functioning PD catheter
• Stable peritoneal dialysis prescription
• PD vintage \> 3 months
• Age \>18 years of age
Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Contact Information
Primary
Veena Rao, PHD
veena.s.rao@yale.edu
203-737-3571
Backup
Kara Otis
kara.otis@yale.edu
203-737-3571
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Empagliflozin or Placebo in Acute
Acute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment.
Active_comparator: Empagliflozin in Chronic
Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim
Leads: Yale University