Status:
RECRUITING
Colchicine in Chronic Kidney Disease Patients
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Conditions:
Chronic Kidney Disease
Cardiovascular Events
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 i...
Detailed Description
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: hemogl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT06998862
Start Date
February 12 2025
End Date
December 30 2028
Last Update
May 31 2025
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain, 28028