REPAIR Study to Reduce Inflammation and Prevent Heart Injury in Adults with Severe Chronic Kidney Disease and Those on Dialysis

What this Trial Is About

Researchers are studying adults with severe chronic kidney disease CKD, including those who do not require dialysis and those who are on chronic maintenance dialysis. This phase 1 basket trial aims to evaluate the tolerance of colchicine at different doses over time to understand its potential to reduce inflammation and prevent cardiovascular injury in people with kidney disease. The study is sponsored by Hamilton Health Sciences Corporation and is designed to include two separate groups one with CKD patients not on dialysis and one with patients receiving dialysis. Participants in both groups will receive open-label colchicine starting at a dose of 0.3 mg daily for 8 weeks. If they tolerate this dose, they will then undergo a forced increase to 0.6 mg daily for another 8 weeks. The study tracks how many adults are able to continue with these doses without stopping the medication. This trial does not include any placebo group and all participants receive colchicine. Each participant will be followed for up to 17 weeks. During this time, researchers will monitor drug adherence, reasons for stopping colchicine if applicable, and any major side effects. The main outcomes measured are dose tolerance and early discontinuations of colchicine during the study period. Participants will provide informed consent and undergo regular assessments to help researchers understand the safety and tolerability of colchicine in this population.

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