Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

Recruiting now · Phase 1

Conditions studied: Chronic Kidney Diseases, Renal Failure

In brief

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.

Key facts

Study ID

NCT06203977

Run by

Hamilton Health Sciences Corporation

People needed

200

Starts

2024-11-15

Expected to finish

2026-05-31

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada
• London Health Sciences Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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