Status:
RECRUITING
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Hamilton Academic Health Sciences Organization
St. Joseph's Health Care London
Conditions:
Chronic Kidney Diseases
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
The REPAIR CKD cohort will enroll 100 patients with chronic kidney disease not requiring dialysis. The REPAIR Dialysis cohort will enroll 100 patients with chronic kidney disease requiring chronic mai...
Eligibility Criteria
Inclusion
- One of either:
- 2 Estimated GFR using CKD-EPI 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (REPAIR CKD cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (REPAIR Dialysis cohort);
- Age ≥18 years
- Provide informed consent to participate.
Exclusion
- Currently treated with and cannot withdraw colchicine due to medical necessity; or
- Known allergy/sensitivity to colchicine; or
- Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or
- Currently pregnant or planning to become pregnant or breastfeed during the study; or
- Of childbearing potential AND do not have a negative pregnancy test OR do not agree to use two forms of contraception for the duration of the study; or
- Anticipated living donor renal transplant within the next 6 months; or
- Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or
- B12 deficiency not managed with intramuscular supplementation; or
- Uncontrolled chronic diarrhea; or
- Cirrhosis, or chronic active hepatitis; or
- Pre-existent neuromuscular disease or persistent serum CK level \> 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or
- Patient with any of the following within the past 60 days:
- white blood cell count \< 3.0 X 109/L; or
- platelet count \<110 X 109/L; or
- ALT or AST \> 3 times the upper limit of normal (ULN); or
- total bilirubin \> 2 times ULN and not due to Gilbert syndrome.
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06203977
Start Date
November 15 2024
End Date
May 31 2026
Last Update
March 12 2025
Active Locations (3)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5