Low-dose colchicine to prevent heart problems in people with moderate chronic kidney disease

Efficacy of Colchicine in Secondary Prevention of Vascular Events and Renal Progression in Patients With Moderate Chronic Kidney Disease

This trial will test whether taking low-dose colchicine reduces future cardiovascular events in adults with moderate chronic kidney disease who have had prior heart or vascular problems.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 744 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Hospital General Universitario Gregorio Marañon (other)
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT06998862 on ClinicalTrials.gov

What this trial studies

ColchiRen is a randomized, double-blind, placebo-controlled Phase 3 trial enrolling 744 adults with moderate CKD (eGFR 30–59) and prior cardiovascular disease. Participants are assigned to low-dose colchicine or placebo and followed for three years to record cardiovascular and renal events. The primary focus is secondary prevention of cardiovascular events while secondary analyses will explore inflammation-related biomarkers and effects on CKD progression using blood, urine, and centralized molecular assays. Outcomes include a composite of major cardiovascular events and predefined renal endpoints, with regular laboratory monitoring and centralized sample analysis.

Who should consider this trial

Good fit: Adults aged 18–99 with moderate CKD (eGFR 30–59 mL/min/1.73 m²) who have a history of prior cardiovascular events or documented coronary artery disease.

Not a fit: People with severe kidney failure (eGFR <30), known colchicine allergy or current colchicine use, recent hospital admission, or active malignancy are unlikely to qualify or benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could lower the risk of major cardiovascular events and may slow kidney disease progression in this high-risk population.

How similar studies have performed: Previous large trials have shown that low-dose colchicine reduces cardiovascular events in non-CKD populations, but evidence is limited specifically in patients with moderate chronic kidney disease.

Eligibility criteria

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.

Where this trial is running

Madrid, Madrid

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

Conditions: Chronic Kidney Disease, Cardiovascular Events