Canagliflozin to improve ultrafiltration and reduce peritoneal fibrosis in people on peritoneal dialysis
Official title: Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06913647 · Data updated 2026-11-12
We will test whether taking canagliflozin reduces glucose absorption by the peritoneal membrane and improves ultrafiltration in people on peritoneal dialysis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | February 28, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT06913647 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with kidney failure on peritoneal dialysis who have used dextrose-based solutions for at least three months and are classified as high or high‑average transporters on PET are the intended participants.
✕Probably not a fit
People who are low or low‑average transporters, have active peritonitis or tunnel infection, are pregnant or breastfeeding, have severe liver disease, a planned transplant within six months, or other contraindications to canagliflozin are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II, double-blind, placebo-controlled, cross-over randomized trial enrolls adults on peritoneal dialysis who are high or high‑average transporters. Participants are randomized 2:2:1 to alternating 5‑week double‑blind periods of canagliflozin 300 mg daily and placebo followed by 16 weeks of open‑label canagliflozin, or to 26 weeks of standard care. Peritoneal equilibration tests at scheduled visits measure ultrafiltration and glucose absorption while dialysate is analyzed for biomarkers of inflammation, angiogenesis, and fibrosis; safety blood tests are performed at weeks 2 and 7. Study visits include baseline, week 5, week 10, a phone check at week 18, and a final visit at week 26.
Why it matters
Potential benefit: If successful, canagliflozin could help preserve peritoneal membrane function, improve ultrafiltration, and slow development of dialysis-related fibrosis, potentially prolonging effective peritoneal dialysis.
How similar studies have gone: While systemic SGLT‑2 inhibitors have shown kidney and cardiovascular benefits in other CKD populations, using canagliflozin to reduce peritoneal glucose absorption and prevent peritoneal fibrosis is largely novel and has not been tested in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with kidney failure on PD (both incident and prevalent) who are on a stable prescription of dextrose-based solutions for at least 3 months. * Only high or high-average transporters, as classified by PET, will be included. Exclusion Criteria: * History of euglycemic ketoacidosis * Known hypersensitivity to canagliflozin * Active peritonitis or tunnel infection * Kidney transplant scheduled in the next 6 months * Severe liver cirrhosis (Child-Pugh class C stage) * Recurrent severe genital or urine infections * Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these agents cannot be safely discontinued * Pregnancy or breastfeeding
Where it's running
-
Research Institute-McGill University Health Center
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Thomas A. Mavrakanas, MD, MSc. — Research Institute-McGill University of Health Centre
- Study coordinator: Efrosyne Tsirella
- Email: efrosyne.tsirella@muhc.mcgill.ca
- Phone: 514-934-1934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.