Colchicine in Chronic Kidney Disease Patients

Recruiting Phase 3 Interventional Study
Chronic Kidney Disease Cardiovascular Events
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
744 (estimated)
Sponsor
Hospital General Universitario Gregorio Marañon · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Age between 18 and 99 years. Moderate chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) by the CKD-EPI formula between 30 and 59 mL/min/1.73 m². History of a previous cardiovascular event: Acute coronary syndrome. Admission for angina pectoris. …
Contacts

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