Investigating the safety and mechanisms of SGLT2 inhibitors in patients on peritoneal dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: vesta.lai@uhn.ca
• Phone: 416-340-4800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.