Status:
RECRUITING
Safety and Efficacy of Canagliflozin in Advanced CKD
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
ESRD
CKD Stage 4
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study objective is to characterize the pharmacokinetics (PK), pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD, including those receiving HD. A...
Detailed Description
Substudy 1: Patients with eGFR\<30 ml/min/1.73m2 and urine albumin to creatinine ratio (UACR)\>200 mg/g not receiving dialysis will receive canagliflozin 100 mg po daily for 12 weeks (phase 1). For p...
Eligibility Criteria
Inclusion
- (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
- 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
Key Trial Info
Start Date :
November 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05309785
Start Date
November 24 2022
End Date
June 1 2026
Last Update
January 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
McGill University Health Center
Montreal, Quebec, Canada