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

NCT ID: NCT05671991

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empagliflozin 25 mg vs Placebo

Intervention Type: DRUG

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

Empagliflozin in Chronic

Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

Group Type: ACTIVE_COMPARATOR

Empagliflozin 10 MG

Intervention Type: DRUG

Chronic Study- Empagliflozin 10 mg for 8 weeks

Interventions

Empagliflozin 25 mg vs Placebo

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

Intervention Type: DRUG

Empagliflozin 10 MG

Chronic Study- Empagliflozin 10 mg for 8 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Testani, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Veena Rao, PHD

Role: CONTACT

veena.s.rao@yale.edu

203-737-3571

Kara Otis

Role: CONTACT

kara.otis@yale.edu

203-737-3571

Facility Contacts

Veena Rao, PhD

Role: primary

Other Identifiers

2000031605

Identifier Type: -

Identifier Source: org_study_id