NCT06913647 Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
| NCT ID | NCT06913647 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | ESRD |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-02-01 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD. The primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.
Eligibility 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
Contact & Investigator
Thomas A. Mavrakanas, MD, MSc.
PRINCIPAL INVESTIGATOR
Research Institute-McGill University of Health Centre
Frequently Asked Questions
Who can join the NCT06913647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ESRD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06913647 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06913647 currently recruiting?
Yes, NCT06913647 is actively recruiting participants. Contact the research team at efrosyne.tsirella@muhc.mcgill.ca for enrollment information.
Where is the NCT06913647 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06913647 clinical trial?
NCT06913647 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Thomas A. Mavrakanas, MD, MSc. at Research Institute-McGill University of Health Centre. The trial plans to enroll 30 participants.