Recruiting

EMPA-PDEmpagliflozin Impact on Peritoneal and Kidney Function in End Stage Renal Disease

Study Aim

This study aims to compare the total glucose absorption between Empagliflozin and a placebo in individuals with End Stage Renal Disease.

What is being tested

Empagliflozin 25 mg vs Placebo

+ Empagliflozin 10 MG

Drug

Who is being recruted

Over 18 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Phase 4

Interventional

Study Start: March 2023

See protocol details

Summary

Principal SponsorYale University

Study ContactVeena Rao, PHDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2023

Actual date on which the first participant was enrolled.

This study focuses on understanding the effect of a medication called Empagliflozin on kidney function in individuals with End Stage Renal Disease. The goal is to compare how well the kidneys absorb glucose when using Empagliflozin versus a placebo, a pill that looks like the real medicine but contains no active ingredients. This research is important as it aims to provide insights into how this drug could potentially benefit individuals with advanced kidney disease. The study spans over 9 weeks, during which participants will attend three main visits and up to four safety checks. In the first visit, participants will take a single dose of either 25mg Empagliflozin or a placebo. After a week, they will return for the second visit to take the alternate option. Following this, all participants will be given 10mg Empagliflozin tablets to take daily for 56 days. At each visit, participants will undergo a PET test to measure how well their kidneys are absorbing glucose. The study also evaluates the safety of Empagliflozin use in this population.

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

NCT05671991

Principal SponsorYale University

Study ContactVeena Rao, PHDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Patients actively undergoing PD with a reliably functioning PD catheter

Stable peritoneal dialysis prescription

PD vintage > 3 months

Age >18 years of age

6 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Yale University

New Haven, United StatesOpen Yale University in Google Maps

Recruiting

One Study Center