Recruiting
Phase 2

Canagliflozin

Sponsor:

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

Code:

NCT06182839

Conditions

ESRD, CKD Stage 4, CKD Stage 5

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Canagliflozin 300Mg Tab

Placebo

Study Details

Brief 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.

Conditions

ESRD, CKD Stage 4, CKD Stage 5

Study ID

NCT06182839

Start date

May 1, 2024

Status verified date

Dec, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Mar 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • LV hypertrophy, defined as LV mass > 130 g/m2 in men and 100 g/m2 in females OR hospitalization for heart failure or atherosclerotic cardiovascular (CV) disease in the last 12 months OR type 2 diabetes OR UACR > 200 mg/g on a morning spot urine collection (this criterion is not applicable to patients who are on dialysis and have a urine output < 500 ml per day).

Exclusion Criteria:

  • type 1 diabetes,
  • history of euglycemic ketoacidosis,
  • known hypersensitivity to sodium-glucose cotransporter-2 (SGLT-2) inhibitors,
  • hemodynamic instability (defined as current use of parenteral inotropic agents),
  • systolic BP < 90 mmHg,
  • severe liver cirrhosis (Child-Pugh class C stage),
  • acute hepatitis (defined as an alanine aminotransferase > 2.0 times the upper limit of normal \[ULN\] or total bilirubin >1.5 times the ULN),
  • recurrent severe genital or urine infections,
  • patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these agents cannot be safely discontinued (due to inhibition of the P-glycoprotein mediated efflux of digoxin by canagliflozin or induction of Uridine 5'-diphospho-glucuronosyltransferase enzymes by the other agents),
  • cardiac MRI-incompatible cardiac devices (cardiac pacemaker, implanted cardiac defibrillator, internal pacing wires, Swan-Ganz catheter, aneurysm clips),
  • claustrophobia,
  • cochlear implants,
  • metallic body in the eyes,
  • pregnancy or breastfeeding,
  • and any other medical condition considered to be a contra-indication by the study physician.

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Canagliflozin (Invokana) 300 mg tablet

placebo comparator: Placebo tablet

Interventions

Canagliflozin 300Mg Tab

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

Placebo

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

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 and Locations

Central contacts

Efrosyne Tsirella, Research Assistant

514-934-1934efrosyne.tsirella@muhc.mcgill.ca

Norka Rios, Research Nurse

514-934-1934norka.rios@muhc.mcgill.ca

Locations

McGill University Health Center

Recruiting

Montreal, Quebec, Canada

Contacts

Norka Rios

5149341934

More Information

Sponsor

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

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Canagliflozin, Advanced CKD, ESRD, Hemodialysis, Peritoneal dialysis, Cardiac MRI, SGLT-2 inhibitors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-12-08.