Recruiting

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

Sponsor:

Yale University

Code:

NCT05671991

Conditions

End Stage Renal Disease on Dialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 mg vs Placebo

Empagliflozin 10 MG

Study Details

Brief 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.

Conditions

End Stage Renal Disease on Dialysis

Study ID

NCT05671991

Start date

Mar 1, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Patients actively undergoing PD with a reliably functioning PD catheter
2. Stable peritoneal dialysis prescription
3. PD vintage > 3 months
4. Age >18 years of age

Exclusion Criteria:

1. History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
2. Use of an SGLT2 inhibitor within the prior 30 days
3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
4. Anemia with hemoglobin <8g/dL
5. Inability to give written informed consent or follow study protocol
6. Contraindication to receiving loop diuretics

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Empagliflozin 25 mg vs Placebo

Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7

Empagliflozin 10 MG

Chronic Study- Empagliflozin 10 mg for 8 weeks

Primary outcome measure

Glucose absorption with empagliflozin vs. placebo [ Time Frame: Day 0 to Day 63 ]

Central Contacts and Locations

Central contacts

Veena Rao, PHD

203-737-3571 veena.s.rao@yale.edu

Kara Otis

203-737-3571 kara.otis@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

Peritoneal dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-22.