Investigating the safety and mechanisms of SGLT2 inhibitors in patients on 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

This study is testing if a diabetes medication called empagliflozin is safe and helpful for people on peritoneal dialysis who still have some kidney function, to see if it can protect their heart and kidneys.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT05715814 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and mechanisms of SGLT2 inhibition using empagliflozin in patients undergoing peritoneal dialysis who have residual kidney function. It focuses on understanding how these inhibitors can potentially protect cardiovascular and kidney health in this unique patient population. The study will involve a two-week intervention period, assessing patients' responses to the medication and gathering mechanistic data that could inform future larger trials. The findings may provide insights into novel therapeutic strategies for patients on renal replacement therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are on peritoneal dialysis with residual kidney function.

Not a fit: Patients with type 1 diabetes or those who have had recent acute coronary syndrome or cerebrovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients on peritoneal dialysis, potentially slowing the loss of kidney function and enhancing cardiovascular health.

How similar studies have performed: While SGLT2 inhibitors have shown benefits in other populations, this specific application in patients on dialysis has not been previously studied, making it a novel approach.

Eligibility 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.).

Where this trial is running

Toronto, Ontario

• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Sunita KS Singh, MD MSc FRCPC — University Health Network, Toronto General Hospital
• Study coordinator: Vesta Lai

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