NCT05715814RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- 1 Sept 2024
- Primary completion date
- 1 May 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Chronic kidney disease
- NCT number
- NCT05715814
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 20
- From 1 Sept 2024 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (in the 30 days prior to screening) acute coronary syndrome or cerebrovascular event.
- Planned surgery/procedures or radiologic investigations requiring contrast during 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.
Other illness
- Type 1 diabetes.
- History of organ transplant, including pancreas, pancreatic islet cells or kidney transplant.
- 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.
- 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.).
Other
- PD peritonitis within 30 days of screening.
- Pregnant, planning to become pregnant, or nursing an infant during the study period
- Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
- Patient not able to understand and comply with study requirements, based on Investigator's judgment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.