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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
colchicine treatment in chronic kidney disease patients
Drugcolchicine treatment 0.5 mg/day
placebo treatment
Drugplacebo treatment 1 pill/day
Treatment groups
744 Participants
are divided into 2 treatment groupsGroup A: Colchicine treatmentActive comparator 1 intervention
Group B: placebo treatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiovascular events
Incidence of the primary event consisting of death due to cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or non-cardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical or percutaneous revascularization."
Time frame
from enrollment to the end of treamtent at three yearsSecondary outcomes
1
cardiovascular death
Incidence of death due to cardiovascular causes.
Time frame
from enrollment to the end of treamtent at three years2
Acute coronary syndrome
Incidence of acute coronary syndrome
Time frame
from enrollment to the end of treamtent at three years3
Angina pectoris
Incidence of hospitalization for angina pectoris.
Time frame
from enrollment to the end of treamtent at three years4
stroke
Incidence of transient ischemic attack or non-cardioembolic ischemic stroke.
Time frame
from enrollment to the end of treamtent at three yearsSponsors and contacts
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Source ClinicalTrials.gov