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Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis

RecruitingPhase 2Ages 18 Years - anyAllMcGill University Health Centre/Research Institut…
NCT06913647 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Canagliflozin 300 MG
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Where

1 site
Research Institute-McGill University Health Center
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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