meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.).