NCT05309785CompletedPhase 4
Safety and Efficacy of Canagliflozin in Advanced CKD
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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. As the CV and renoprotective effects of SGLT-2 inhibitors appear to be independent of glycemic control, the investigators hypothesize that canagliflozin will reduce albuminuria in patients with advanced CKD in the same manner as observed in patients with higher eGFR. The investigators also hypothesize that the 300 mg dose will be equally safe as the 100 mg dose but will have greater efficacy, given data which suggests efficacy correlates with drug exposure in patients without CKD. Given its negligible renal elimination, the investigators hypothesize that exposure to canagliflozin 100 mg at steady state will not exceed the standard bioequivalence boundary of 80-125% in patients receiving HD, compared with published estimates with the 300 mg dose at steady state in individuals with preserved kidney function.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 14 Mar 2022
- Start date
- 24 Nov 2022
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- Chronic kidney disease
- NCT number
- NCT05309785
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 34
- From 24 Nov 2022 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
- Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir will be excluded if these agents cannot be safely discontinued
Other illness
- 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
- gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
- any other clinical condition that would jeopardize patient safety while participating in this trial.
Lab values
- 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
Age
- Age \<18 years
Other
- pregnancy
- currently breastfeeding
Who the study is looking for
- (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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.