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New treatment option for ESRD, CKD Stage 4, CKD Stage 5
Official title Canagliflozin in Advanced Renal Disease With MRI Endpoints
ClinicalTrials.gov ID: NCT06182839
What this study is testing
What is Canagliflozin 300Mg Tab?
Canagliflozin 300Mg Tab is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for esrd, ckd stage 4, ckd stage 5.
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 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.
- 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's taking place
- 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 - 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?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.