Safety and Efficacy of Canagliflozin in Advanced CKD

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ (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.

Locations
Other Locations
Canada
McGill University Health Center
RECRUITING
Montreal
Contact Information
Primary
Norka Rios
norka.rios@muhc.mcgill.ca
514-934-1934
Time Frame
Start Date: 2022-11-24
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 44
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov