ESRD, CKD Stage 4, CKD Stage 5 study: Canagliflozin
Official title Canagliflozin in Advanced Renal Disease With MRI Endpoints
ClinicalTrials.gov ID: NCT06182839
What this study is testing
What is Canagliflozin 300 mg tablet?
an investigational oral medicine being studied as a potential treatment to improve heart structure and function in patients with advanced chronic kidney disease is designed to block the sodium‑glucose co‑transporter‑2 (SGLT2) in the kidneys, causing glucose and sodium loss in the urine
Also referred to as Invokana (generic name canagliflozin).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if canagliflozin improves the structure and function of the heart compared to a placebo in patients with advanced kidney disease.
- Who it's for
- The study is looking for people with advanced chronic kidney disease, including those who are on dialysis.
- What's involved
- Participants will take canagliflozin or a placebo and undergo cardiac magnetic resonance imaging (MRI) to check heart health.
- Time commitment
- The source text does not specify the duration of the study or the number of visits required.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- advanced CKD, defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 not yet on dialysis OR incident hemodialysis or...
- 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...
You likely can't join if
- 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),
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.