Status:
NOT_YET_RECRUITING
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
ESRD
CKD (Chronic Kidney Disease) Stage 5D
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. ...
Detailed Description
Patients with kidney failure on peritoneal dialysis who meet the study inclusion criteria will be randomized at a 2:2:1 ratio to one of the following arms: (i) canagliflozin 300 mg once daily for 5 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06913647
Start Date
September 1 2025
End Date
September 1 2028
Last Update
April 6 2025
Active Locations (1)
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1
Research Institute-McGill University Health Center
Montreal, Quebec, Canada