Reducing inflammation to prevent heart injury in kidney disease
Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)
This study is testing if a medication called colchicine can help reduce inflammation and prevent heart injury in people with chronic kidney disease, both those who need dialysis and those who don’t.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 3 sites (Edmonton, Alberta and 2 other locations) |
| Trial ID | NCT06203977 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial includes two open-label cohorts: one for patients with chronic kidney disease (CKD) not requiring dialysis and another for those requiring dialysis. Participants will receive colchicine, starting at a dose of 0.3 mg daily for 8 weeks, which may be increased to 0.6 mg daily if tolerated. The study aims to evaluate the proportion of patients who can continue treatment without discontinuation over a total follow-up period of up to 17 weeks. The trial will enroll 200 patients in total, with 100 in each cohort.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease either not requiring dialysis or those receiving chronic maintenance dialysis.
Not a fit: Patients who are currently intolerant to colchicine or have a known allergy to it will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to reduce cardiovascular injury in patients with chronic kidney disease.
How similar studies have performed: Other studies have explored colchicine's effects in various conditions, but this specific approach in chronic kidney disease is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta and 2 other locations
- University of Alberta Hospital — Edmonton, Alberta, Canada (Not_yet_recruiting)
- St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Michael Walsh, MD, PhD — McMaster University
- Study coordinator: Courtney Christou, BSc
- Email: courtney.christou@phri.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.