Actively Recruiting
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Led by Hamilton Health Sciences Corporation · Updated on 2025-03-12
200
Participants Needed
3
Research Sites
80 weeks
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
H
Hamilton Academic Health Sciences Organization
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort. Open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.
CONDITIONS
Official Title
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have either an estimated GFR of 30 ml/min/1.73m2 or less on at least two occasions separated by at least 2 months and are not on dialysis and not expected to need dialysis in the next 6 months, or are receiving chronic maintenance dialysis two or more times per week for the previous 90 days
- Able and willing to provide informed consent to participate
You will not qualify if you...
- Currently treated with colchicine and unable to stop it due to medical necessity
- Known allergy or sensitivity to colchicine
- Prior intolerance to colchicine at a dose of 0.6 mg daily or lower
- Currently pregnant, planning to become pregnant, or breastfeeding during the study
- Of childbearing potential without a negative pregnancy test or unwilling to use two forms of contraception during the study
- Anticipated living donor kidney transplant within the next 6 months
- Use of strong inhibitors of p-glycoprotein or CYP3A4 within the last 14 days
- Unmanaged vitamin B12 deficiency
- Uncontrolled chronic diarrhea
- Cirrhosis or chronic active hepatitis
- Pre-existing neuromuscular disease or persistent elevated serum creatine kinase levels
- Recent low white blood cell count, low platelet count, elevated liver enzymes, or high bilirubin not due to Gilbert syndrome
- Considered unsuitable for the study by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Not Yet Recruiting
Research Team
C
Courtney Christou, BSc
CONTACT
J
Jessica Tyrwhitt, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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