Canagliflozin in Advanced Renal Disease With MRI Endpoints

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT06182839
Phase
PHASE2
Status
Recruiting
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Conditions

  • ESRD, CKD Stage 4, CKD Stage 5

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin 300Mg Tab — DRUG
    Patients will get 1 pill of Canagliflozin 300 mg daily for one year.
  • Placebo — DRUG
    Patients will get 1 pill of placebo daily for one year.

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Dec 2025
Primary completion
Mar 30, 2028
Completion
Mar 30, 2029

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Canagliflozin (Invokana) 300 mg tablet
  • Placebo Comparator: Placebo tablet

Primary Outcome Measure

Change in left ventricular mass to volume ratio (LVMV) from baseline to 12 months, as assessed by cardiac MRI compared with placebo [ Time Frame: 12 months ]

Central Contacts