A Phase 2 interventional study of Canagliflozin 300Mg Tab and Placebo in ESRD, CKD Stage 4, CKD Stage 5, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2, Interventional, and Treatment
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.
Patients with advanced renal disease, including those on maintenance dialysis, will be randomized to receive canagliflozin 300 mg orally once daily or matching placebo for one year. For patients who are not yet on renal replacement therapy, the study medication will be continued when they transition to dialysis or when they get a kidney transplant.
The prescription of all other medications, including dialysis prescription for dialysis-dependent patients, will be left to the treating physician's discretion. We will discourage changes to medications during follow-up unless deemed clinically necessary. All medications changes will be recorded at each visit.
Symptoms and adverse events will be monitored closely. Participants who experience adverse events classified as severe and probably or definitely related to the study medication will be withdrawn. Patients who develop intercurrent illnesses, are hospitalized, or have surgery (urgent or elective) will temporarily discontinue the drug.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 92 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
advanced CKD, defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 not yet on dialysis OR incident hemodialysis or peritoneal dialysis patients (i.e., who were started on dialysis in the last 6 months)*
* For patients who were not previously followed in a CKD clinic and for whom it is not clear whether dialysis was initiated after an acute deterioration in renal function that is potentially reversible, at least 90 days of dialysis will be required prior to enrolment. This criterion only applies to patients for whom baseline eGFR prior to the acute event was ≥ 20 ml/min/1.73m2 or was unknown. The average creatinine values over the last 12 months will be used to calculate baseline eGFR.
Exclusion Criteria:
Drug: Canagliflozin 300Mg Tab
Drug: Placebo
Patients will get 1 pill of Canagliflozin 300 mg daily for one year.
Patients will get 1 pill of placebo daily for one year.
Change in left ventricular mass to volume ratio (LVMV) from baseline to 12 months, as assessed by cardiac MRI compared with placebo
Assessed on cardiac magnetic resonance imaging (MRI)
Time frame: 12 months
Changes in left ventricular (LV) and atrial volumes from baseline to 12 months compared with placebo
Assessed on cardiac MRI
Time frame: 12 months
LV strain parameter changes from baseline to 12 months compared with placebo
Long-axis fractional shortening on cardiac MRI
Time frame: 12 months
Changes in myocardial edema and fibrosis from baseline to 12 months compared with placebo
Use of magnetic resonance imaging T2 and T1 maps, respectively (software cvi42).
Time frame: 12 months
Change in myocardial oxygenation reserve from baseline to 12 months compared with placebo
Use of oxygenation-sensitive cardiovascular magnetic resonance (OS-CMR) sequences.
Time frame: 12 months
Composite of major adverse cardiovascular events
Cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure.
Time frame: 12 months
Death from any cause
Time frame: 12 months
Progression to kidney failure (only for patients not yet on maintenance dialysis).
Initiation of maintenance hemodialysis, peritoneal dialysis, or renal transplantation.
Time frame: 12 months
Difference in distance in the 6-minute walk test at 12 months from baseline
Time frame: 12 months
Difference in dyspnea score at 12 months from baseline
Using the 7-point Likert scale and Visual analog scale questionnaire.
Time frame: 12 months
Difference in quality of life at 12 months from baseline
Using the Kansas City Cardiomyopathy questionnaire.
Time frame: 12 months
Change in urine albumin to creatinine ratio (UACR) from baseline (only for patients not yet on maintenance dialysis) at 6 and 12 months
Time frame: 6 months and 12 months
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time frame: 6 months and 12 months
Change in iron profile
Time frame: 6 months and 12 months
Change in tubular injury biomarkers
For patients not yet on maintenance dialysis.
Time frame: 6 months and 12 months
Change in dose of erythropoietin-stimulating agents at 12 months from baseline
Time frame: 12 months
Change in 24-hour ambulatory blood pressure at 12 months from baseline
Time frame: 12 months
Composite of serious adverse events
Severe hyperkalemia (\>6 mmol/l), acute kidney injury (≥ stage 2 using the AKIN criteria), and euglycemic ketoacidosis.
Time frame: 12 months
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McGill University Health Centre/Research Institute of the McGill University Health Centre