A Phase 3 interventional study of colchicine treatment in chronic kidney disease patients and placebo treatment in Chronic Kidney Disease and Cardiovascular Events, sponsored by Hospital General Universitario Gregorio Marañon. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 3, Interventional, and Prevention
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:
Cardiovascular events defined as one of the following:
Renal event, defined as one of the following:
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's planned enrollment of 744 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Hospital General Universitario Gregorio Marañon is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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. Transient ischemic attack or non-cardioembolic ischemic stroke. Coronary revascularization. Peripheral vasculopathy, defined as: embolism or acute peripheral arterial ischemia, or the need for amputation or surgical revascularization.
Finding of coronary artery disease on imaging test.
Exclusion Criteria:
History of hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal ligation.
Documented infertility. Postmenopausal women, defined as amenorrhea for more than 12 months without other medical cause. In case of doubt, confirmation with elevated follicle-stimulating hormone (FSH) levels is recommended.
Women of reproductive capacity must use a method of contraception with proven effectiveness until 8 weeks after the end of the study. Acceptable methods include:
Intrauterine device (IUD) placement at least 6 weeks before study inclusion. Hormonal contraception with progestogens only, associated with ovulation inhibition: oral, injectable, or implantable, at least 6 weeks before study inclusion.
Progestin-releasing intrauterine system (IUS) at least 6 weeks before study inclusion.
Combined hormonal contraception (containing estrogen and progestogens) associated with ovulation inhibition: oral, intravaginal, transdermal, at least 6 weeks before study inclusion.
Other contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for participation in this study
after randomization, a 0.5 mg tablet of colchicine per day will be administered.
Drug: colchicine treatment in chronic kidney disease patients
after randomization 0,25 mg of placebo per day will be administered
Drug: placebo treatment
colchicine treatment 0.5 mg/day
placebo treatment 1 pill/day
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 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.
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
Started Feb 2025 (actual). Primary completion is estimated for Dec 2028, 46 months after the start.
Of 39 non-industry phase 3 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 62. This study's planned 46 months is close to that.
Counting every sponsor, half of 153 studies reached it within 31 months; a quarter within 19 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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Hospital General Universitario Gregorio Marañon