NCT06203977 Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
| NCT ID | NCT06203977 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2024-11-15 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Michael Walsh, MD, PhD
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT06203977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06203977 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06203977 currently recruiting?
Yes, NCT06203977 is actively recruiting participants. Contact the research team at courtney.christou@phri.ca for enrollment information.
Where is the NCT06203977 trial being conducted?
This trial is being conducted at Edmonton, Canada, Hamilton, Canada, London, Canada.
Who is sponsoring the NCT06203977 clinical trial?
NCT06203977 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Michael Walsh, MD, PhD at McMaster University. The trial plans to enroll 200 participants.
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