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

NCT05671991 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2000031605
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• Glucose absorption with empagliflozin vs. placebo

  Total glucose absorption in grams with empagliflozin vs. placebo

  Day 0 to Day 63

Secondary Outcomes (6)

• Ultrafiltration volume with empagliflozin vs. placebo- acute study

  at 4 hours

• Change in plasma glucose levels with empagliflozin vs. placebo- acute study

  Day 0 to Day 63

• Increase in natriuresis with empagliflozin vs. placebo-acute study

  Day 0 to Day 63

• Change in peritoneal fluid inflammatory markers

  Day 0 to Day 63

• Change in PET test parameters

  Day 0 to Day 63

Study Arms (2)

Empagliflozin or Placebo in Acute

EXPERIMENTAL

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

Empagliflozin in Chronic

ACTIVE COMPARATOR

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

Drug: Empagliflozin 10 MG

Interventions

Empagliflozin 25 mg vs Placebo DRUG

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

Empagliflozin or Placebo in Acute

Empagliflozin 10 MG DRUG

Chronic Study- Empagliflozin 10 mg for 8 weeks

Empagliflozin in Chronic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients actively undergoing PD with a reliably functioning PD catheter
• Stable peritoneal dialysis prescription
• PD vintage \> 3 months
• Age \>18 years of age

You may not qualify if:

• 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
• Use of an SGLT2 inhibitor within the prior 30 days
• or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
• Anemia with hemoglobin \<8g/dL
• Inability to give written informed consent or follow study protocol
• Contraindication to receiving loop diuretics

Sponsors & Collaborators

• Yale University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Interventions

empagliflozin

Study Officials

• Jeffrey Testani, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veena Rao, PHD

CONTACT

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

Kara Otis

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 5, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)