Colchicine in Chronic Kidney Disease Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorHospital General Universitario Gregorio Marañon
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
History of allergy or intolerance to colchicine or any of its excipients (dihydrate calcium hydrogen phosphate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate).
Current treatment with colchicine, or within the month prior to inclusion.
Hospital admission for any cause within the 3 months prior to study inclusion.
Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasm who have remained disease-free for the past 3 years may be included.
Trial design
Treatments tested in this trial
- colchicine treatment in chronic kidney disease patients
- placebo treatment
Treatment groups
744 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov