Active, Not Recruiting
This study is ongoing but no longer accepting new participants.
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
About This Study
REPAIR is a Phase 1 open-label basket trial evaluating the safety and tolerability of colchicine in patients with CKD or ESRD requiring maintenance dialysis. Participants receive 0.3 mg of colchicine daily for 8 weeks, followed by a forced titration to 0.6 mg daily for an additional 8 weeks in those who tolerate the initial dose. The primary objective is to determine the proportion of patients in each cohort who discontinue treatment at both the 0.3 mg and 0.6 mg dose levels. The study aims to establish a feasible dosing regimen for future investigations into reducing cardiovascular injury via inflammation reduction in this high-risk population.
Who Can Participate?
✓ Inclusion Criteria
- •One of either: 1.2 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 Criteria
- •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.