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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
colchicine treatment 0.5 mg/day
placebo treatment 1 pill/day
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
RECRUITINGCardiovascular 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 years
cardiovascular death
Incidence of death due to cardiovascular causes.
Time frame: from enrollment to the end of treamtent at three years
Acute coronary syndrome
Incidence of acute coronary syndrome
Time frame: from enrollment to the end of treamtent at three years
Angina pectoris
Incidence of hospitalization for angina pectoris.
Time frame: from enrollment to the end of treamtent at three years
stroke
Incidence of transient ischemic attack or non-cardioembolic ischemic stroke.
Time frame: from enrollment to the end of treamtent at three years
Peripheral vasculopathy
Incidence of peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.
Time frame: from enrollment to the end of treamtent at three years
renal disease progression
Individual and combined incidence of renal events: A 40% decrease in estimated glomerular filtration rate (eGFR) by CKD-EPI compared to baseline, doubling of serum creatinine over its baseline level, Persistent decline in estimated glomerular filtration rate (eGFR) by CKD-EPI below 15 mL/min/1.73 m² or need for sustained renal replacement therapy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
744
Time frame: from enrollment to the end of treamtent at three years
effect of colchcine treatment on inflammation and fibrosis parameters
At the baseline, annual and final visits of the study, an additional blood sample will be obtained, which will be frozen at -80º and sent for centralized analysis at the Renal Physiopathology Laboratory of the Hospital General Universitario Gregorio Marañón. The measurement will be performed using cytokine arrays (Human Inflammation Array, RayBiotech®) with which the measurement of 40 inflammatory/profibrotic and anti-inflammatory factors is contemplated, including among others: TNFα, TNFβ, IL2, IL6, IL7, IL1α, IL1β, IL17A RANTES, ICAM-1, TIMP-1, TIMP-2, GCSF and M-CSF.
Time frame: from enrollment to the end of treatment at three years
Security
Incidence of adverse events.
Time frame: from enrollment to the end of treatment at three years