Phase II Trial of Canagliflozin Effects on Peritoneal Dialysis Function and Fibrosis in Adults with Kidney Failure

What this Trial Is About

Researchers are evaluating the effects of canagliflozin, an SGLT-2 inhibitor, on peritoneal membrane function in patients with kidney failure undergoing peritoneal dialysis PD. This phase II, placebo-controlled, double-blind, crossover randomized clinical trial aims to determine how canagliflozin affects glucose absorption by the peritoneal membrane and ultrafiltration, using a standardized peritoneal equilibrium test. The study also explores the drugs impact on inflammation, angiogenesis, fibrosis, and solute clearance over 26 weeks, through analysis of biomarkers in the dialysate. Participants will be assigned in a 221 ratio to one of three groups one group will receive canagliflozin 300 mg daily for 5 weeks followed by placebo for 5 weeks, then canagliflozin for 16 weeks the second group will receive placebo for 5 weeks, then canagliflozin for 5 weeks, followed by canagliflozin for 16 weeks the third group will receive standard care without active treatment for 26 weeks. The first two phases are double-blind, while the last 16 weeks are open-label. Study visits occur at baseline, week 5, week 10, week 18 phone visit, and week 26, with safety blood tests at weeks 2 and 7. Temporary discontinuation of study drug is possible if medical conditions arise. Participants will undergo a standardized peritoneal equilibration test during in-person visits to assess membrane function. Researchers will measure changes in glucose absorption, ultrafiltration, solute clearance, and biomarkers related to inflammation, angiogenesis, and fibrosis. Other assessments include kidney function, blood pressure, 6-minute walk test, dyspnea score, quality of life, cardiovascular events, and safety outcomes over 26 weeks. This comprehensive monitoring ensures careful evaluation of the treatments short- and medium-term effects.

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