Actively Recruiting
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
Led by University Health Network, Toronto · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the safety and mechanisms of SGLT2 inhibitors in people on peritoneal dialysis who still have some residual kidney function. This study addresses the need for new treatments to protect heart and kidney health in these patients, including those with and without type 2 diabetes. The research aims to understand how these drugs work in dialysis patients and guide future larger studies and treatment decisions beyond end-stage kidney disease. Participants will receive 25 mg of empagliflozin once daily by mouth for two weeks in an open-label, single-arm study. The study focuses on patients with residual kidney function undergoing peritoneal dialysis. Researchers will monitor changes in kidney function and other health markers during and shortly after the treatment period to evaluate the drug's effects and safety. During the study, participants will undergo assessments including measurements of kidney filtration rate, urine and dialysate analysis, blood pressure, body weight and composition, blood tests for HbA1c and other markers related to heart, kidney, and metabolic health. Safety will be closely monitored for complications such as infections, volume depletion, or diabetic ketoacidosis. The total participation time includes baseline and two-week follow-up evaluations, with detailed monitoring of kidney and cardiovascular responses.
CONDITIONS
Brief Title
meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent
- Patients aged 18 years or older on peritoneal dialysis with residual kidney function defined as at least 250 cc urine output per day
- Measured glomerular filtration rate of at least 2 ml/min/1.73m2 within the last 3 months
- Stable peritoneal dialysis prescription
- Stable dose of RAAS blockade medication for at least 30 days if applicable
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Acute coronary syndrome or cerebrovascular event within 30 days prior to screening
- Peritoneal dialysis peritonitis within 30 days of screening
- History of organ transplant including pancreas, islet cells, or kidney
- Planned surgery or radiologic procedures requiring contrast during the trial
- Pregnant, nursing, or planning pregnancy during the study
- History of diabetic ketoacidosis
- Blood disorders causing hemolysis or unstable red blood cells at screening
- Alcohol or drug abuse within 3 months prior to screening
- Use of SGLT2 inhibitors within 30 days prior to screening
- Participation in another investigational drug trial within 30 days prior to screening
- Inability to understand or comply with study requirements
- Any other condition judged by investigators to pose safety risks or affect study outcomes (e.g., immunocompromised status, active cancer, uncontrolled hypertension, severe liver impairment)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants take once daily 25mg of Empagliflozin while on peritoneal dialysis to evaluate safety and efficacy.
Visits during the 2-week treatment period
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G2N2
Actively Recruiting
Research Team
V
Vesta Lai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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