AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Colchicine in Chronic Kidney Disease Patients

RecruitingPhase 3Ages 18 Years - 99 YearsAllHospital General Universitario Gregorio Marañon
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. 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 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. * Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.). * Active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus. * Liver cirrhosis of any cause, grade B or C according to Child-Pugh. * Immunosuppressive treatment within the 12 weeks prior to study inclusion. * Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs). * Poorly controlled hypertension (\>160/90 mmHg) at the time of inclusion. * Pregnancy and breastfeeding at the time of inclusion. Contraceptive methods are required for women of reproductive age. Women with no capacity for pregnancy are considered to be those with: 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 * Gastric ulcer * thrombocytopenia \<50,000 cells/μL during the month prior to inclusion * Neutropenia defined as \<1500 cells/mcL during the month prior to inclusion. * Anemia defined as hemoglobin \<10.5 g/dL during the month prior to inclusion. * History of aplastic anemia diagnosed through bone marrow biopsy. * Treatment with CYP3A4 inhibitors and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cyclosporine) in the month prior to their inclusion in the study.
💊

What it tests

  • colchicine treatment in chronic kidney disease patients
  • placebo treatment
📍

Where

1 site
Hospital General Universitario Gregorio Marañon
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy