Recruiting
Phase 2

Canagliflozin

Sponsor:

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

Code:

NCT06913647

Conditions

ESRD

CKD (Chronic Kidney Disease) Stage 5D

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Canagliflozin 300 MG

Study Details

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.

Conditions

ESRD

CKD (Chronic Kidney Disease) Stage 5D

Study ID

NCT06913647

Start date

Feb 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active treatment followed by placebo

Canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by matching placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label)

placebo comparator: Placebo followed by active treatment

Placebo once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 5 weeks (double-blind), followed by canagliflozin 300 mg once daily for 16 weeks (open label)

no intervention: Standard of care

Standard of care, with no active treatment, for 26 weeks (open label)

Interventions

Canagliflozin 300 MG

Canagliflozin 300 mg once daily

Primary outcome measure

  • Change in D4/D0 [ Time Frame: 5 and 10 weeks from baseline ]

Central Contacts and Locations

Central contacts

Efrosyne Tsirella

514-934-1934efrosyne.tsirella@muhc.mcgill.ca

Norka Rios

514-934-1934norka.rios@muhc.mcgill.ca

Locations

Research Institute-McGill University Health Center

Recruiting

Montreal, Quebec, Canada

Contacts

Efrosyne Tsirella

5149341934efrosyne.tsirella@muhc.mcgill.ca

Norka Rios

514-934-1934norka.rios@muhc.mcgill.ca

More Information

Sponsor

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

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • SGLT-2 inhibitors
  • Canagliflozin
  • Ultrafiltration failure
  • Peritoneal fibrosis
  • Peritoneal dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-16.