EMPA-PD: Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

Sponsor

Yale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05671991

Collaborator

Boehringer Ingelheim (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease on Dialysis	Drug: Empagliflozin 25 mg vs Placebo Drug: Empagliflozin 10 MG	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Empagliflozin 25 mg vs Placebo Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Active Comparator: Empagliflozin in Chronic Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks	Drug: Empagliflozin 10 MG Chronic Study- Empagliflozin 10 mg for 8 weeks

Arm

Intervention/Treatment

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.

Drug: Empagliflozin 25 mg vs Placebo

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

Active Comparator: Empagliflozin in Chronic

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

Drug: Empagliflozin 10 MG

Chronic Study- Empagliflozin 10 mg for 8 weeks

Outcome Measures

Primary Outcome Measures

Glucose absorption with empagliflozin vs. placebo [Day 0 to Day 63]
Total glucose absorption in grams with empagliflozin vs. placebo

Secondary Outcome Measures

Ultrafiltration volume with empagliflozin vs. placebo- acute study [at 4 hours]
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Change in plasma glucose levels with empagliflozin vs. placebo- acute study [Day 0 to Day 63]
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Increase in natriuresis with empagliflozin vs. placebo-acute study [Day 0 to Day 63]
Natriuresis determined by FENa
Change in peritoneal fluid inflammatory markers [Day 0 to Day 63]
Change in levels of IL-6 and CA-125 (in pg)
Change in PET test parameters [Day 0 to Day 63]
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)
Change in total body water and extracellular water [Day 0 to Day 63]
Change in total body water and extracellular water, using heaving water (D20)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients actively undergoing PD with a reliably functioning PD catheter
Stable peritoneal dialysis prescription
Chronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics)
PD vintage > 3 months
24 Hour urine output >400 ml
Age >18 years of age

Exclusion Criteria:

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
1 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yale University
Boehringer Ingelheim

Investigators

Principal Investigator: Jeffrey Testani, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT05671991

Other Study ID Numbers:

2000031605

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 5, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Yale University

Peritoneal dialysis

Additional relevant MeSH terms:

Kidney Diseases

Kidney Failure, Chronic

Empagliflozin

Study Results

No Results Posted as of Jan 5, 2023