Your session is about to expire
← Back to Search
SGLT-2 Inhibitor
Canagliflozin for Chronic Kidney Disease (SIP-AKiD Trial)
Phase 4
Recruiting
Led By Thomas Mavrakanas, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
(Substudy 1- SIP-AKiD-1): adult patients with eGFR <30 ml/min/1.73m2
(Substudy 2- SIP-AKiD-2): without significant residual renal function, defined as a urine output <250 ml/24h
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 and 26 weeks
Awards & highlights
SIP-AKiD Trial Summary
This trial will help researchers understand if the drug canagliflozin is safe and effective in reducing albuminuria (a marker for kidney damage) in patients with advanced chronic kidney disease, including those receiving dialysis.
Who is the study for?
Adults with advanced chronic kidney disease (CKD) can join this trial. For one part, they need an eGFR <30 ml/min/1.73m2 and high urine albumin but not on dialysis. Another part is for those on hemodialysis for at least 3 months without much remaining kidney function. People under 18, with type 1 diabetes, recent SGLT-2 inhibitor use, severe liver disease, certain medication use that can't be stopped, or who are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The trial tests Canagliflozin's effects in CKD patients including those on hemodialysis (HD). It aims to see if the drug reduces protein in urine and has cardiovascular/kidney protection benefits as seen in less severe cases. Two doses of Canagliflozin (100 mg and 300 mg) will be compared for safety and effectiveness.See study design
What are the potential side effects?
Canagliflozin may cause side effects like genital or urinary tract infections; however specific side effects related to advanced CKD or HD patients will be closely monitored given their unique health situation.
SIP-AKiD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is low, with an eGFR under 30.
Select...
I produce less than 250 ml of urine in 24 hours.
Select...
I am not on dialysis.
SIP-AKiD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 and 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 and 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The 26-week change in albuminuria compared to baseline, as assessed by the UACR.
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.
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Bronchial Provocation Tests
Change in 6-minute walk distance from baseline
+3 moreOther outcome measures
Change in urinary excretion of phosphate from baseline
Effective half-life (t1/2)
Peak plasma concentration (Cmax)
+2 moreFind a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,682 Total Patients Enrolled
Thomas Mavrakanas, MDPrincipal InvestigatorResearch Institute of the McGill University Health Center
2 Previous Clinical Trials
117 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I frequently have severe genital or urinary infections.I have no GI surgeries or disorders affecting medication absorption.I have had an amputation, gangrene, or an active skin ulcer without injury.You have any other medical condition that could put your safety at risk during the trial.I am not taking digoxin, phenobarbital, phenytoin, rifampin, or ritonavir, or I can safely stop if needed.My kidney function is low, with an eGFR under 30.I have been on hemodialysis for at least 3 months.I produce less than 250 ml of urine in 24 hours.My liver function tests are significantly above normal, or I have liver cirrhosis.I am not on dialysis.I have not taken any SGLT-2 inhibitors in the last 48 hours.I have type 1 diabetes.I have had ketoacidosis with normal blood sugar levels.You have a known allergy or sensitivity to SGLT-2 inhibitors.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate goal of this trial?
"The primary outcome of this 8-day trial is to evaluate the 26-week change in albuminuria as assessed by UACR. This will be complemented with a secondary assessment, which seeks to measure the 6-minute walk distance from baseline for substudy 1, alter urinary excretion of sodium from baseline (for substudy 1), and compare UACR changes between 300 mg dose at 26 weeks and 100 mg dose at 12 weeks versus baseline (for substudy 1)."
Answered by AI
What evidence is there to suggest that this treatment is risk-free for patients?
"The safety rating of this therapeutic treatment is a 3 due to the successful completion of Phase 4 trial, indicating that it has been sanctioned."
Answered by AI
Are any positions still available for prospective participants of this experiment?
"The information on clinicaltrials.gov attests to the fact that this experiment is not presently seeking out candidates, as it was last updated on September 5th 2022. Despite this, there are still 21 other medical trials actively enrolling participants at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger