Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06203977

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

Led by Hamilton Health Sciences Corporation · Updated on 2025-03-12

200

Participants Needed

3

Research Sites

80 weeks

Total Duration

On this page

Sponsors

H

Hamilton Health Sciences Corporation

Lead Sponsor

H

Hamilton Academic Health Sciences Organization

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Have either an estimated GFR of 30 ml/min/1.73m2 or less on at least two occasions separated by at least 2 months and are not on dialysis and not expected to need dialysis in the next 6 months, or are receiving chronic maintenance dialysis two or more times per week for the previous 90 days
  • Able and willing to provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Currently treated with colchicine and unable to stop it due to medical necessity
  • Known allergy or sensitivity to colchicine
  • Prior intolerance to colchicine at a dose of 0.6 mg daily or lower
  • Currently pregnant, planning to become pregnant, or breastfeeding during the study
  • Of childbearing potential without a negative pregnancy test or unwilling to use two forms of contraception during the study
  • Anticipated living donor kidney transplant within the next 6 months
  • Use of strong inhibitors of p-glycoprotein or CYP3A4 within the last 14 days
  • Unmanaged vitamin B12 deficiency
  • Uncontrolled chronic diarrhea
  • Cirrhosis or chronic active hepatitis
  • Pre-existing neuromuscular disease or persistent elevated serum creatine kinase levels
  • Recent low white blood cell count, low platelet count, elevated liver enzymes, or high bilirubin not due to Gilbert syndrome
  • Considered unsuitable for the study by the investigator for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2B7

Not Yet Recruiting

2

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada, L8N 4A6

Actively Recruiting

3

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Not Yet Recruiting

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Research Team

C

Courtney Christou, BSc

CONTACT

J

Jessica Tyrwhitt, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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