Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Canagliflozin 300 MG.
- Who it may be relevant to
- Registry conditions: ESRD, CKD (Chronic Kidney Disease) Stage 5D. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial
Overview
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.
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 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).
(ii) 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).
(iii) standard of care, with no active treatment, for 26 weeks (open label). Four in-person and one phone study visits have been scheduled: baseline visit, week 5, week 10, week 18 (phone visit), and week 26. A standardized peritoneal equilibration test (PET) will be performed at each of the in-person visits. There will also be two safety assessments at weeks 2 and 7, which will consist of blood tests. Patients who develop intercurrent illnesses or are hospitalized may temporarily discontinue the study drug if deemed appropriate by the treating physician.
Interventions
- Drug Canagliflozin 300 MG
Canagliflozin 300 mg once daily
Primary outcome measures
- Change in D4/D0 [Time frame: 5 and 10 weeks from baseline]
Secondary outcome measures (12)
- Change in ultrafiltration [Time frame: 5 and10 weeks from baseline]
- Change in sodium dip/ sieving [Time frame: 5 and 10 weeks from baseline]
- Change in small solute clearance [Time frame: 5 and10 weeks from baseline]
- Canagliflozin levels in the dialysate [Time frame: 5 and10 weeks from baseline]
- Change in small and middle solute clearance [Time frame: 26 weeks from baseline]
- Change in effluent biomarker levels [Time frame: 26 weeks from baseline]
- Change in residual kidney function [Time frame: 26 weeks from baseline]
- Change in blood pressure [Time frame: 26 weeks from baseline]
- 6-minute walk test [Time frame: 26 weeks from baseline]
- Change in dyspnea score [Time frame: 26 weeks from baseline]
- Change in quality of life [Time frame: 26 weeks from baseline]
- Major adverse cardiovascular events [Time frame: 26 weeks from baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Research Institute-McGill University Health Center — Montreal
Identifiers
NCT: NCT06913647 · 2025-11346