RecruitingPhase 1NCT06203977

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


Sponsor

Hamilton Health Sciences Corporation

Enrollment

200 participants

Start Date

Nov 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (REPAIR) tests whether low-dose colchicine — an anti-inflammatory medication used for gout — can reduce heart disease risk in people with advanced chronic kidney disease (CKD) or those already on dialysis, who have very high rates of heart attacks and strokes. **You may be eligible if...** - You have advanced chronic kidney disease (estimated kidney function of 30 mL/min or below) but are not yet on dialysis, OR you have been on regular dialysis for at least 90 days - You are 18 or older - You are willing to give informed consent **You may NOT be eligible if...** - You currently take colchicine and cannot stop it for medical reasons - You have a known allergy to colchicine or previously could not tolerate it at low doses - You are pregnant, planning to become pregnant, or breastfeeding - You have a condition that would make colchicine unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine

0.3mg and 0.6mg tablets


Locations(3)

University of Alberta Hospital

Edmonton, Alberta, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06203977


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