NCT06998862

Colchicine in Chronic Kidney Disease Patients

Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 744 (estimated)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The ColchiRen study is a phase 3, controlled, prospective, randomized, double-blind, and multicenter clinical trial. Its main objective is to demonstrate the benefit of low-dose colchicine treatment in secondary prevention of cardiovascular events in patients with moderate CKD. As a secondary objective, it aims to explore the potential beneficial anti-inflammatory effect on the progression of CKD.

Detailed description

A total of 744 patients will be included (50% in each branch), and the follow-up time of the study will be three years. EXPLORATORY PARAMETERS * Analytical parameters in blood: * Hemogram: hemoglobin, erythrocyte sedimentation rate. * Biochemistry: creatinine, glomerular filtration rate estimated by CKD-EPI, glucose, triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol, uric acid, C-reactive protein, fibrinogen, glycosylated hemoglobin. * Analytical parameter in urine: albumin/creatinine ratio in first morning urine. * Parameters in samples centralized in the Renal Pathophysiology Laboratory: array including more than 40 molecules that promote and inhibit inflammation and fibrosis; measurement of ACE and ACE2. * Cardiovascular events defined as one of the following: * Cardiovascular death. * Acute coronary syndrome. * Angina requiring hospitalization. * Coronary revascularization. * Transient ischemic attack or noncardioembolic ischemic stroke. * Peripheral vascular disease, defined as acute peripheral arterial embolism or ischemia, or need for amputation or percutaneous surgical revascularization. * Renal event, defined as one of the following: * 40% decrease in glomerular filtration rate estimated by CKD-EPI with respect to baseline. * Doubling of serum creatinine above baseline. * Persistent drop in glomerular filtration rate estimated by CKD-EPI below 15 mL/min/1.73m2. * Need for renal replacement therapy

Conditions

• Chronic Kidney Disease
• Cardiovascular Events

Interventions

Type	Name	Description
DRUG	colchicine treatment in chronic kidney disease patients	colchicine treatment 0.5 mg/day
DRUG	placebo treatment	placebo treatment 1 pill/day

Timeline

• Start date: 2025-02-12
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: Spain