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

Kidney Dysfunction End-stage Kidney Disease Peritoneal Dialysis Complication Sodium-glucose Co-transporter-2 Inhibitors Residual Kidney Function

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

Inclusion Criteria4

Signed and dated written informed consent.
Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine output per day (assessed via 24-hour urine collection) and a minimum measured GFR of 2 ml/min/1.73m2, as measured at least once in the last 3 months.
Stable PD prescription, as determined by investigators.
Stable dose of RAAS blockade if on a medication within this class for the last 30 days.

Exclusion Criteria14

Type 1 diabetes.
Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.
PD peritonitis within 30 days of screening.
History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.
Planned surgery/procedures or radiologic investigations requiring contrast during the trial.
Pregnant, planning to become pregnant, or nursing an infant during the study period
History of any DKA event
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening.
Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
Alcohol or drug abuse within the 3 months prior to screening that would interfere with trial participation based on Investigator's judgement.
Use of SGLT2 inhibitor within 30 days prior to screening.
Intake of an investigational drug in another trial within 30 days prior to screening.
Patient not able to understand and comply with study requirements, based on Investigator's judgment.
Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome, severe hepatic impairments etc.).