COLCHICINE IN SECONDARY PREVENTION OF VASCULAR EVENTS AND RENAL PROGRESSION IN PATIENTS WITH MODERATE CHRONIC RENAL DISEASE

Phase 1

• Conditions: CHRONIC RENAL DISEASE; MedDRA version: 20.0Level: LLTClassification code: 10051051Term: Renal disease Class: 10038359; Therapeutic area: Not possible to specify

• Registration Number: CTIS2023-505868-11-00
• Lead Sponsor: Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 744

Inclusion Criteria

Age between 18 and 99 years. - Moderate chronic kidney disease, defined as a glomerular filtration rate estimated by the CKD-EPI formula between 30 and 59 mL/min/1.73m2. - History of having suffered a previous cardiovascular event: o Acute coronary syndrome. o Admission for angina pectoris. o Transient ischemic attack or non-cardioembolic ischemic stroke. o Coronary revascularization. o Peripheral vasculopathy, defined as: embolism or acute peripheral arterial ischemia, or need for amputation or percutaneous surgical revascularization. o Finding of coronary artery disease on imaging test. - Legal capacity and voluntary willingness to sign informed consent.

Exclusion Criteria

- History of allergy or intolerance to colchicine or any of its excipients (calcium hydrogen phosphate dihydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate). - Current treatment with colchicine, or during the month prior to inclusion. - Hospital admission of any cause in the 3 months prior to inclusion in the study. - Active malignant neoplasm (except non-melanoma skin cancer or carcinoma in situ). Patients with a history of malignant neoplasia who have remained free of disease during the previous 3 years can be included. - Uncontrolled or symptomatic chronic inflammatory disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, etc.). - Active infection by hepatitis B virus, hepatitis C virus or human immunodeficiency virus. - Liver cirrhosis of any cause Child-Pugh grade B or C. - Immunosuppressive treatment in the 12 weeks prior to inclusion in the study. - Chronic treatment with non-steroidal anti-inflammatory drugs. - Poorly controlled arterial hypertension (>160/90 mmHg) at the inclusion visit., - Pregnancy and lactation in the inclusion. The use of contraceptive methods is required for women with gestational capacity. Women with gestational capacity are not considered those with: o History of hysterectomy, double salpingectomy, double oophorectomy, or bilateral tubal ligation. o Documented infertility. o Postmenopausal women, defined as amenorrhea for more than 12 months with no other medical cause. In case of doubt, confirmation with elevated follicle stimulating hormone (FSH) levels is recommended. In women with gestational capacity, the use of a contraceptive method of proven effectiveness is required up to 8 weeks after the end of the study. Acceptable methods are as follows: o intrauterine device (IUD) implantation at least 6 weeks prior to study inclusion. o Progestogen-only hormonal contraception associated with ovulation inhibition: oral, injectable, implantable at least 6 weeks prior to study enrollment. o Intrauterine progestin-releasing system at least 6 weeks prior to study enrollment. Combined hormonal contraception (containing estrogens and progestogens) associated with ovulation inhibition : oral, intravaginal , transdermal at least since 6 weeks prior to study inclusion. Other contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for the study., - Gastric ulcer. - Thrombocytopenia defined as <50000 cells/mcL 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 by bone marrow biopsy. - Treatment with CYP3A4 and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cisclosporin) in the month prior to inclusion in the trial. Treatment with CYP3A4 and/or P-glycoprotein inhibitors (antivirals, azole antifungals, aminoglycosides, cisclosporin) in the month prior to inclusion in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified