drugset / Trial / NCT06913647

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

NCT06913647

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2026-02-01
Primary completion
2028-02-28
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator CANAGLIFLOZIN ANHYDROUS Small molecule 300 mg