Evaluating Canagliflozin for Patients with Advanced Chronic Kidney Disease

Safety and Efficacy of Canagliflozin in Advanced CKD

This study is testing if canagliflozin is safe and effective for people with advanced chronic kidney disease, including those on dialysis, to see how it affects their kidney function and protein levels in urine.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (other)
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT05309785 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of canagliflozin in patients with advanced chronic kidney disease (CKD), including those on hemodialysis. It consists of two substudy phases: one for patients not on dialysis with severe CKD and another for those receiving hemodialysis. Participants will receive canagliflozin at varying doses to evaluate its impact on kidney function and albuminuria levels. The study will monitor pharmacokinetics and surrogate efficacy outcomes over a defined treatment period.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced CKD (eGFR <30 ml/min/1.73m2) and high urine albumin levels, as well as those on hemodialysis for at least three months.

Not a fit: Patients with type 1 diabetes, significant liver disease, or those who have recently used SGLT-2 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option to slow the progression of kidney disease in patients with advanced CKD.

How similar studies have performed: Other studies have shown promising results with SGLT-2 inhibitors in CKD, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

(Substudy 1- SIP-AKiD-1):

* adult patients with eGFR \<30 ml/min/1.73m2
* urine albumin to creatinine ratio (UACR) \>200 mg/g
* not receiving dialysis.

(Substudy 2- SIP-AKiD-2):

* adult patients on hemodialysis for at least 3 months
* without significant residual renal function, defined as a urine output \<250 ml/24h.

Exclusion Criteria:

* Age \<18 years
* type 1 diabetes
* history of euglycemic ketoacidosis
* known hypersensitivity to SGLT-2 inhibitors
* recurrent severe genital or urinary tract infections
* history of atraumatic amputation, gangrene, or active skin ulcer
* use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
* liver disease defined by an ALT \> 3.0 times the upper limit of normal \[ULN\] or total bilirubin \>1.5 times the ULN or liver cirrhosis of any stage
* gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
* pregnancy
* currently breastfeeding
* any other clinical condition that would jeopardize patient safety while participating in this trial.
* Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir will be excluded if these agents cannot be safely discontinued

Where this trial is running

Montreal, Quebec

• McGill University Health Center — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Thomas Mavrakanas, MD — Research Institute of the McGill University Health Center
• Study coordinator: Norka Rios

Conditions: ESRD, CKD Stage 4, CKD Stage 5, Canagliflozin, Advanced CKD, Hemodialysis, Safety, Efficacy