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

Phase 1

Recruiting

• Conditions: Renal Failure; Chronic Kidney Diseases
• Interventions: Drug: Colchicine

• Registration Number: NCT06203977
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

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 maintenance dialysis. Each participant will be followed for up to 17 weeks, to determine among adults with severe chronic kidney disease not requiring dialysis and (separately) in those requiring dialysis, the proportion who, over 8 weeks of treatment, discontinue colchicine 1) 0.3 mg daily and 2) 0.6 mg daily.

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-12
• Study Start: 2024-11-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 donor renal transplant within the next 6 months; or

7. Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or

8. B12 deficiency not managed with intramuscular supplementation; or

9. Uncontrolled chronic diarrhea; or

10. Cirrhosis, or chronic active hepatitis; or

11. 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

12. 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.

13. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REPAIR Dialysis cohort	Colchicine	Patients will receive 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.
REPAIR CKD cohort	Colchicine	Patients will receive 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.

Primary Outcome Measures

Name	Time	Method
Dose tolerance	Up to 17 weeks	Proportion of participants who permanently discontinue colchicine at either the 0.3 mg daily dose or 0.6 mg daily dose (to estimate the proportion who would discontinue the study drug at the 0.6 mg daily dose without titration).
Early discontinuations	Up to 17 weeks	Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.

Secondary Outcome Measures

Name	Time	Method
Reason for drug discontinuation	Up to 17 weeks	To determine the reasons for temporary and permanent discontinuations of colchicine at the 0.3 mg and 0.6 mg daily doses.
Major Side Effects	Up to 17 weeks	To determine the risk of major side effects of colchicine at the 0.3 mg and 0.6 mg daily doses.
Drug adherence	Up to 17 weeks	To determine degree of adherence to colchicine at the 0.3 mg and 0.6 mg daily doses.

Trial Locations

Locations (3)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada