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Canagliflozin in Advanced Renal Disease With MRI Endpoints

Study acronym: CARe-MRI
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 30, 2024 to May 1, 2024
    v3
  3. Primary endpoint revised
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (17)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06182839
Lead Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Heart and Stroke Foundation of Canada
Conditions
(from sponsor)		 ESRD, CKD Stage 4, CKD Stage 5
Related terms Kidney Failure, Chronic, Renal Insufficiency, Chronic
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov