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

Primary Purpose

End Stage Renal Disease on Dialysis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Empagliflozin 25 mg vs Placebo
Empagliflozin 10 MG
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End Stage Renal Disease on Dialysis focused on measuring Peritoneal dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Empagliflozin or Placebo in Acute

Empagliflozin in Chronic

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Glucose absorption with empagliflozin vs. placebo
Total glucose absorption in grams with empagliflozin vs. placebo

Secondary Outcome Measures

Ultrafiltration volume with empagliflozin vs. placebo- acute study
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
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
Increase in natriuresis with empagliflozin vs. placebo-acute study
Natriuresis determined by FENa
Change in peritoneal fluid inflammatory markers
Change in levels of IL-6 and CA-125 (in pg)
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)
Change in total body water and extracellular water
Change in total body water and extracellular water, using heaving water (D20)

Full Information

First Posted
December 14, 2022
Last Updated
May 1, 2023
Sponsor
Yale University
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05671991
Brief Title
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Acronym
EMPA-PD
Official Title
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
Peritoneal dialysis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin or Placebo in Acute
Arm Type
Experimental
Arm Description
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.
Arm Title
Empagliflozin in Chronic
Arm Type
Active Comparator
Arm Description
Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 25 mg vs Placebo
Intervention Description
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
Chronic Study- Empagliflozin 10 mg for 8 weeks
Primary Outcome Measure Information:
Title
Glucose absorption with empagliflozin vs. placebo
Description
Total glucose absorption in grams with empagliflozin vs. placebo
Time Frame
Day 0 to Day 63
Secondary Outcome Measure Information:
Title
Ultrafiltration volume with empagliflozin vs. placebo- acute study
Description
Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.
Time Frame
at 4 hours
Title
Change in plasma glucose levels with empagliflozin vs. placebo- acute study
Description
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
Time Frame
Day 0 to Day 63
Title
Increase in natriuresis with empagliflozin vs. placebo-acute study
Description
Natriuresis determined by FENa
Time Frame
Day 0 to Day 63
Title
Change in peritoneal fluid inflammatory markers
Description
Change in levels of IL-6 and CA-125 (in pg)
Time Frame
Day 0 to Day 63
Title
Change in PET test parameters
Description
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
Title
Change in total body water and extracellular water
Description
Change in total body water and extracellular water, using heaving water (D20)
Time Frame
Day 0 to Day 63

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Keith
Phone
203-737-3571
Email
katherine.keith@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Veena Rao, PHD
Phone
203-737-3571
Email
veena.s.rao@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Testani, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Keith

12. IPD Sharing Statement

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

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