Actively Recruiting
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) Phase 1 Trial of Colchicine in Chronic Kidney Disease and Dialysis Patients
Led by Hamilton Health Sciences Corporation · Updated on 2025-03-12
200
Participants Needed
3
Research Sites
N/A
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
Researchers are studying adults with severe chronic kidney disease (CKD), including those who do not require dialysis and those who are on chronic maintenance dialysis. This phase 1 basket trial aims to evaluate the tolerance of colchicine at different doses over time to understand its potential to reduce inflammation and prevent cardiovascular injury in people with kidney disease. The study is sponsored by Hamilton Health Sciences Corporation and is designed to include two separate groups: one with CKD patients not on dialysis and one with patients receiving dialysis. Participants in both groups will receive open-label colchicine starting at a dose of 0.3 mg daily for 8 weeks. If they tolerate this dose, they will then undergo a forced increase to 0.6 mg daily for another 8 weeks. The study tracks how many adults are able to continue with these doses without stopping the medication. This trial does not include any placebo group and all participants receive colchicine. Each participant will be followed for up to 17 weeks. During this time, researchers will monitor drug adherence, reasons for stopping colchicine if applicable, and any major side effects. The main outcomes measured are dose tolerance and early discontinuations of colchicine during the study period. Participants will provide informed consent and undergo regular assessments to help researchers understand the safety and tolerability of colchicine in this population.
CONDITIONS
Brief 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 chronic kidney disease with an estimated GFR of 30 ml/min/1.73m2 or less on at least two occasions at least 2 months apart and not expected to require dialysis in the next 6 months (REPAIR CKD cohort), or
- Receiving chronic maintenance dialysis at least twice per week for the past 90 days (REPAIR Dialysis cohort)
- Able and willing to provide informed consent to participate
You will not qualify if you...
- Currently treated with colchicine and cannot stop it due to medical necessity
- Known allergy or sensitivity to colchicine
- Previous intolerance to colchicine at doses of 0.6 mg daily or lower
- Currently pregnant, planning to become pregnant, or breastfeeding
- Of childbearing potential without a negative pregnancy test or unwilling to use two forms of contraception during the study
- Expected to have a living donor kidney transplant within 6 months
- Use of strong inhibitors of p-glycoprotein or CYP3A4 within the last 14 days
- Untreated vitamin B12 deficiency
- Uncontrolled chronic diarrhea
- Liver diseases such as cirrhosis or chronic active hepatitis
- Pre-existing neuromuscular disease or persistently elevated creatine kinase levels
- Recent abnormal blood counts or liver function tests within the past 60 days
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 16 weeks
Participants take colchicine tablets starting with 0.3 mg daily for 8 weeks. Those who tolerate this dose then increase to 0.6 mg daily for an additional 8 weeks.
Duration - Up to 1 week after treatment
Participants are monitored for up to 17 weeks to assess dose tolerance, drug adherence, and any side effects after treatment.
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
J
Jessica Tyrwhitt, BSc
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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