RecruitingPhase 3NCT06998862

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


Sponsor

Hospital General Universitario Gregorio Marañon

Enrollment

744 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether colchicine — an anti-inflammatory medication traditionally used for gout — can reduce the risk of cardiovascular events (such as heart attacks and strokes) in patients with moderate chronic kidney disease who have already had a prior heart or vascular event. **You may be eligible if...** - You are between 18 and 99 years old - You have moderate chronic kidney disease (eGFR 30–59 mL/min/1.73 m²) - You have a history of a cardiovascular event such as a heart attack, stroke, bypass surgery, or severe peripheral artery disease **You may NOT be eligible if...** - You have an allergy to colchicine or are already taking it - You have been hospitalized in the past 3 months - You have an active cancer (other than certain cured skin cancers) - You have liver cirrhosis (Child-Pugh B or C), active HIV, active hepatitis B or C - You have low blood counts, a stomach ulcer, or are pregnant or breastfeeding - You are taking certain antifungal or antiviral medications that interact with colchicine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcolchicine treatment in chronic kidney disease patients

colchicine treatment 0.5 mg/day

DRUGplacebo treatment

placebo treatment 1 pill/day


Locations(1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

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NCT06998862


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