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

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Jan 10, 2024

Keywords

ClinConnect Summary

The REPAIR clinical trial is studying whether a medication called colchicine can help reduce inflammation and prevent heart problems in people with chronic kidney diseases. This trial includes two groups: one for patients who have kidney disease but do not yet need dialysis, and another for those who are already on dialysis. Participants will take colchicine for a total of 16 weeks, starting with a lower dose for the first 8 weeks, which may be increased if tolerated.

To be eligible for the study, participants must be at least 18 years old and either have a specific level of kidney function that indicates severe kidney disease but do not need dialysis yet, or have been undergoing dialysis for the past three months. It’s important to note that certain health conditions or medications may prevent someone from joining the study. Participants will be closely monitored throughout the trial to ensure their safety and to see how well the treatment works. This study is currently recruiting participants, and anyone interested should discuss it with their healthcare provider to see if they qualify.

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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.