Safety and Efficacy of Canagliflozin in Advanced CKD
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.
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.
Phase:
Phase 4
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre