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

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.