A Phase 4 interventional study of Empagliflozin 25 mg vs Placebo and Empagliflozin 10 MG in End Stage Renal Disease on Dialysis, sponsored by Yale University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Yale University · Phase 4, Interventional, and Other
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.
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.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Empagliflozin 25 mg vs Placebo
Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks
Drug: Empagliflozin 10 MG
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Chronic Study- Empagliflozin 10 mg for 8 weeks
Glucose absorption with empagliflozin vs. placebo
Total glucose absorption in grams with empagliflozin vs. placebo
Time frame: Day 0 to Day 63
Ultrafiltration volume with empagliflozin vs. placebo- acute study
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Time frame: at 4 hours
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Time frame: Day 0 to Day 63
Increase in natriuresis with empagliflozin vs. placebo-acute study
Natriuresis determined by FENa
Time frame: Day 0 to Day 63
Change in peritoneal fluid inflammatory markers
Change in levels of IL-6 and CA-125 (in pg)
Time frame: Day 0 to Day 63
Change in PET test parameters
Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane)
Time frame: Day 0 to Day 63
Change in total body water and extracellular water
Change in total body water and extracellular water, using heaving water (D20)
Time frame: Day 0 to Day 63
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University