RecruitingPhase 2NCT06182839

Canagliflozin in Advanced Renal Disease With MRI Endpoints

Sponsor

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

Enrollment

92 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

ESRD, CKD Stage 4, CKD Stage 5

Summary

This is a phase II, proof of concept, placebo-controlled, randomized clinical trial, assessing the effect of canagliflozin on cardiac structure and function in patients with advanced renal disease, including those on maintenance dialysis. Our primary aim is to determine the effect of canagliflozin on cardiac structure and function in patients with advanced chronic kidney disease (CKD), compared with placebo. We hypothesize that canagliflozin will improve left ventricular (LV) hypertrophy in patients with advanced CKD. Our secondary aims are to describe the effect of canagliflozin on other cardiac magnetic resonance imaging parameters and surrogate markers of efficacy in this population.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether canagliflozin — a diabetes drug that also protects the kidneys — is beneficial for people with very advanced chronic kidney disease (CKD) who are close to needing dialysis or have recently started it. The drug has proven benefits in earlier kidney disease stages, and this study examines if it still helps at this late stage using MRI scans to measure kidney health. **You may be eligible if...** - You have advanced CKD with a very low kidney filtration rate (eGFR below 20 mL/min/1.73m2), OR - You recently started hemodialysis or peritoneal dialysis within the past 6 months - You are not yet on long-term maintenance dialysis **You may NOT be eligible if...** - You have been on dialysis for more than 6 months - You have certain serious heart conditions that would make the drug unsafe - You have a contraindication to canagliflozin or cannot undergo MRI - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCanagliflozin 300Mg Tab

Patients will get 1 pill of Canagliflozin 300 mg daily for one year.

DRUGPlacebo

Patients will get 1 pill of placebo daily for one year.

Locations(1)

McGill University Health Center

Montreal, Quebec, Canada

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NCT06182839