Safety and Efficacy of Canagliflozin in Advanced CKD (NCT05309785) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Safety and Efficacy of Canagliflozin in Advanced CKD
Canada35 participantsStarted 2022-11-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The 26-week change in albuminuria compared to baseline, as assessed by the UACR.
Timeframe: 26 weeks
2
The drug exposure at steady-state with 100 mg, as expressed by the AUC0-24, compared to published estimates with the 300 mg dose in patients with preserved renal function.
Timeframe: 8 days
Trial details
NCT IDNCT05309785
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre