Actively Recruiting
Canagliflozin in Advanced Renal Disease With MRI Endpoints
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2025-12-08
92
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Canagliflozin in Advanced Renal Disease With MRI Endpoints
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced chronic kidney disease with an estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m2 and not yet on dialysis OR started hemodialysis or peritoneal dialysis within the last 6 months
- For patients with unclear dialysis start after an acute kidney event, at least 90 days of dialysis before enrollment if baseline eGFR was 20 ml/min/1.73m2 or higher or unknown
- Left ventricular hypertrophy defined as LV mass over 130 g/m2 in men or over 100 g/m2 in women OR hospitalization for heart failure or atherosclerotic cardiovascular disease in the last 12 months OR type 2 diabetes OR urine albumin-to-creatinine ratio over 200 mg/g on a morning spot urine (not applicable if urine output is less than 500 ml/day in dialysis patients)
You will not qualify if you...
- Type 1 diabetes
- History of euglycemic ketoacidosis
- Known allergy to sodium-glucose cotransporter-2 (SGLT-2) inhibitors
- Hemodynamic instability requiring parenteral inotropic agents
- Systolic blood pressure below 90 mmHg
- Severe liver cirrhosis (Child-Pugh class C)
- Acute hepatitis with elevated liver enzymes or bilirubin
- Recurrent severe genital or urinary infections
- Current use of digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these cannot be safely stopped
- Presence of cardiac MRI-incompatible devices like pacemakers, defibrillators, pacing wires, Swan-Ganz catheter, or aneurysm clips
- Claustrophobia
- Cochlear implants
- Metallic objects in the eyes
- Pregnancy or breastfeeding
- Any other medical condition deemed a contraindication by the study doctor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McGill University Health Center
Montreal, Quebec, Canada
Actively Recruiting
Research Team
E
Efrosyne Tsirella, Research Assistant
CONTACT
N
Norka Rios, Research Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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