RecruitingPhase 3NCT05715814

meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

A Single Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of Once Daily 25mg Empagliflozin in Patients on Peritoneal Dialysis With Residual Kidney Function


Sponsor

University Health Network, Toronto

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary aim of this study is to determine the safety and mechanisms of SGLT2 inhibition in individuals on peritoneal dialysis (PD) with residual kidney function (RKF).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a diabetes medication called an SGLT2 inhibitor (commonly used to protect the kidneys and heart in people with diabetes) is safe and beneficial for people who are on peritoneal dialysis (a home-based form of kidney dialysis) and still produce some urine. Researchers want to understand how it affects kidney fluid balance and safety in this specific group. **You may be eligible if...** - You are 18 or older and on peritoneal dialysis - You still produce at least some urine each day (at least 250 mL/day) and have measurable kidney filtration - Your dialysis prescription has been stable and you have not had recent infections or serious illnesses **You may NOT be eligible if...** - You have Type 1 diabetes - You have had a recent heart attack, stroke, or peritoneal dialysis infection in the past 30 days - You have had an organ transplant (kidney, pancreas) - You are pregnant, planning to become pregnant, or breastfeeding - You have a history of diabetic ketoacidosis (DKA) - You are already taking an SGLT2 inhibitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin 25 MG

PO once daily


Locations(1)

Toronto General Hospital

Toronto, Ontario, Canada

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NCT05715814


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