Colchicine in Chronic Kidney Disease Patients

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Kidney Disease, Cardiovascular Events

In brief

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.

Key facts

Study ID

NCT06998862

Run by

Hospital General Universitario Gregorio Marañon

People needed

744

Starts

2025-02-12

Expected to finish

2028-12-30

Last updated by the study team

2025-05-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.