ESRD, CKD Stage 4, CKD Stage 5Phase 2CARe-MRINCT06182839
Canagliflozin in Advanced Renal Disease With MRI Endpoints
A Phase 2 study testing Canagliflozin 300Mg Tab in people with ESRD, CKD Stage 4, CKD Stage 5, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD, CKD Stage 4, CKD Stage 5
- What is being tested?
- Canagliflozin 300Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 30 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Efrosyne Tsirella, Research Assistant contact
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec
Norka Rios, 5149341934
About this study
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.
Read the detailed description
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.
- Conditions
- ESRD, CKD Stage 4, CKD Stage 5
- Being tested
- Canagliflozin 300Mg Tab, Placebo
- Keywords
- Canagliflozin, Advanced CKD, ESRD, Hemodialysis, Peritoneal dialysis, Cardiac MRI, SGLT-2 inhibitors
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 300Mg TabDrug
Patients will get 1 pill of Canagliflozin 300 mg daily for one year.
PlaceboDrug
Patients will get 1 pill of placebo daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin (Invokana) 300 mg tablet | Active comparator | Not described Receives: Drug: Canagliflozin 300Mg Tab |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (17)
Changes in left ventricular (LV) and atrial volumes from baseline to 12 months compared with placebo
Assessed on cardiac MRI
Measured: 12 months
LV strain parameter changes from baseline to 12 months compared with placebo
Long-axis fractional shortening on cardiac MRI
Measured: 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).
Measured: 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.
Measured: 12 months
Composite of major adverse cardiovascular events
Cardiovascular death, myocardial infarction, stroke, hospitalization for heart failure.
Measured: 12 months
Death from any cause
Measured: 12 months
Progression to kidney failure (only for patients not yet on maintenance dialysis).
Initiation of maintenance hemodialysis, peritoneal dialysis, or renal transplantation.
Measured: 12 months
Difference in distance in the 6-minute walk test at 12 months from baseline
Measured: 12 months
Difference in dyspnea score at 12 months from baseline
Using the 7-point Likert scale and Visual analog scale questionnaire.
Measured: 12 months
Difference in quality of life at 12 months from baseline
Using the Kansas City Cardiomyopathy questionnaire.
Measured: 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
Measured: 6 months and 12 months
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
Measured: 6 months and 12 months
Change in iron profile
Measured: 6 months and 12 months
Change in tubular injury biomarkers
For patients not yet on maintenance dialysis.
Measured: 6 months and 12 months
Change in dose of erythropoietin-stimulating agents at 12 months from baseline
Measured: 12 months
Change in 24-hour ambulatory blood pressure at 12 months from baseline
Measured: 12 months
Composite of serious adverse events
Severe hyperkalemia (>6 mmol/l), acute kidney injury (≥ stage 2 using the AKIN criteria), and euglycemic ketoacidosis.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start1 May 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRD, CKD Stage 4, CKD Stage 5Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a single centre, prospective, randomized, parallel group (Canagliflozin VS placebo), double blind interventional study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Thomas Mavrakanas, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Thomas Mavrakanas, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182839
- Sponsor's protocol ID
- 2024-10313
- Acronym
- CARe-MRI
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canagliflozin in Advanced Renal Disease With MRI Endpoints
- ClinicalTrials.gov ID
- NCT06182839
- Acronym / sponsor ID
- CARe-MRI / 2024-10313
- Conditions
- ESRD, CKD Stage 4, CKD Stage 5
- Keywords
- Canagliflozin, Advanced CKD, ESRD, Hemodialysis, Peritoneal dialysis, Cardiac MRI, SGLT-2 inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will conduct a single centre, prospective, randomized, parallel group (Canagliflozin VS placebo), double blind interventional study.
| Arm | Type | Receives |
|---|---|---|
| Canagliflozin (Invokana) 300 mg tablet | Active comparator | Drug: Canagliflozin 300Mg Tab |
| Placebo tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)*
- 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).
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canagliflozin 300Mg TabPatients will get 1 pill of Canagliflozin 300 mg daily for one year. | Drug | Canagliflozin (Invokana) 300 mg tablet |
| PlaceboPatients will get 1 pill of placebo daily for one year. | Drug | Placebo tablet |
Primary outcome
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
Assessed on cardiac magnetic resonance imaging (MRI)
17 secondary outcomes
Changes in left ventricular (LV) and atrial volumes from baseline to 12 months compared with placebo
Time frame: 12 months
LV strain parameter changes from baseline to 12 months compared with placebo
Time frame: 12 months
Changes in myocardial edema and fibrosis from baseline to 12 months compared with placebo
Time frame: 12 months
Change in myocardial oxygenation reserve from baseline to 12 months compared with placebo
Time frame: 12 months
Composite of major adverse cardiovascular events
Time frame: 12 months
Death from any cause
Time frame: 12 months
Progression to kidney failure (only for patients not yet on maintenance dialysis).
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
Time frame: 12 months
Difference in quality of life at 12 months from baseline
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
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
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Efrosyne Tsirella, Research Assistant contact
Thomas Mavrakanas, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canagliflozin 300Mg Tab in people with ESRD, CKD Stage 4, CKD Stage 5, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efrosyne Tsirella, Research Assistant (514-934-1934 ext. 37836, efrosyne.tsirella@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.