Low-Dose Colchicine to Prevent Cardiovascular Events and Slow Kidney Disease in Moderate Chronic Kidney Disease Patients

What this Trial Is About

Researchers are evaluating the effects of low-dose colchicine treatment in patients with moderate chronic kidney disease CKD to prevent cardiovascular events and explore its potential to reduce inflammation and slow CKD progression. This phase 3, randomized, double-blind, multicenter trial aims to include 744 participants and assess both cardiovascular and kidney-related outcomes over three years. Participants are randomly assigned to receive either 0.5 mg of colchicine daily or a placebo pill once per day. The study will track various blood and urine markers related to inflammation, kidney function, and cardiovascular health. Cardiovascular events such as heart attacks, strokes, and peripheral vascular disease, along with kidney events like significant declines in kidney function or the need for dialysis, will be monitored throughout the treatment period. During the study, participants will have blood and urine tests to check kidney function, inflammation, and cardiovascular risk factors. Researchers will measure outcomes including cardiovascular events, kidney disease progression, and safety. The trial includes regular follow-up visits over the three-year treatment period to monitor health and treatment effects, with detailed laboratory analysis centralized in a specialized laboratory to better understand inflammation and fibrosis mechanisms in CKD patients.

Colchicine in Chronic Kidney Disease Patients