Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
Trial Parameters
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 mg dose, by forced titration to 0.6 mg daily for 8 weeks.
Eligibility Criteria
Inclusion Criteria: 1. 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); 2. Age ≥18 years 3. Provide informed consent to participate. Exclusion Criteria: 1. Currently treated with and cannot withdraw colchicine due to medical necessity; or 2. Known allergy/sensitivity to colchicine; or 3. Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or 4. Currently pregnant or planning to become pregnant or breastfeed during the study; or 5. 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 6. Anticipated living don