Actively Recruiting
Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis Patients: A Proof-of-Concept Phase II Randomized Crossover Trial
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2026-03-16
30
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of canagliflozin, an SGLT-2 inhibitor, on peritoneal membrane function in patients with kidney failure undergoing peritoneal dialysis (PD). This phase II, placebo-controlled, double-blind, crossover randomized clinical trial aims to determine how canagliflozin affects glucose absorption by the peritoneal membrane and ultrafiltration, using a standardized peritoneal equilibrium test. The study also explores the drug's impact on inflammation, angiogenesis, fibrosis, and solute clearance over 26 weeks, through analysis of biomarkers in the dialysate. Participants will be assigned in a 2:2:1 ratio to one of three groups: one group will receive canagliflozin 300 mg daily for 5 weeks followed by placebo for 5 weeks, then canagliflozin for 16 weeks; the second group will receive placebo for 5 weeks, then canagliflozin for 5 weeks, followed by canagliflozin for 16 weeks; the third group will receive standard care without active treatment for 26 weeks. The first two phases are double-blind, while the last 16 weeks are open-label. Study visits occur at baseline, week 5, week 10, week 18 (phone visit), and week 26, with safety blood tests at weeks 2 and 7. Temporary discontinuation of study drug is possible if medical conditions arise. Participants will undergo a standardized peritoneal equilibration test during in-person visits to assess membrane function. Researchers will measure changes in glucose absorption, ultrafiltration, solute clearance, and biomarkers related to inflammation, angiogenesis, and fibrosis. Other assessments include kidney function, blood pressure, 6-minute walk test, dyspnea score, quality of life, cardiovascular events, and safety outcomes over 26 weeks. This comprehensive monitoring ensures careful evaluation of the treatment's short- and medium-term effects.
CONDITIONS
Brief Title
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with kidney failure on peritoneal dialysis who have been on a stable prescription of dextrose-based solutions for at least 3 months
- Patients classified as high or high-average transporters by peritoneal equilibration test (PET)
You will not qualify if you...
- History of euglycemic ketoacidosis
- Known hypersensitivity to canagliflozin
- Active peritonitis or tunnel infection
- Scheduled kidney transplant within the next 6 months
- Severe liver cirrhosis (Child-Pugh class C stage)
- Recurrent severe genital or urinary infections
- Use of digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these cannot be safely stopped
- Pregnancy or breastfeeding
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 - 26 weeks
Participants receive canagliflozin or placebo in a randomized crossover design or standard of care over 26 weeks.
4 in-person visits and 1 phone visit
Duration - Throughout the 26 weeks
Safety assessments and monitoring occur throughout the treatment period including blood tests at weeks 2 and 7.
2 safety blood test visits
Trial Site Locations
Total: 1 location
1
Research Institute-McGill University Health Center
Montreal, Quebec, Canada
Actively Recruiting
Research Team
E
Efrosyne Tsirella
N
Norka Rios
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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