RecruitingPhase 2NCT06913647

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

Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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

Interventions

DRUGCanagliflozin 300 MG

Canagliflozin 300 mg once daily


Locations(1)

Research Institute-McGill University Health Center

Montreal, Quebec, Canada

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NCT06913647


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