Colchicine in Chronic Kidney Disease Patients

NCT06998862 | Recruiting Phase 3 DMC

• 2 other identifiers: FIBHGM-ECNC002-20222023-505868-11-00
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Kidney Disease; Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  Incidence of the primary event consisting of death due to cardiovascular causes; acute coronary syndrome; angina requiring hospitalization; coronary revascularization; transient ischemic attack or non-cardioembolic ischemic stroke; or peripheral vasculopathy, defined as embolism or acute peripheral arterial ischemia, or the need for amputation or surgical or percutaneous revascularization."

  from enrollment to the end of treamtent at three years

Secondary Outcomes (8)

• cardiovascular death

  from enrollment to the end of treamtent at three years

• Acute coronary syndrome

  from enrollment to the end of treamtent at three years

• Angina pectoris

  from enrollment to the end of treamtent at three years

• stroke

  from enrollment to the end of treamtent at three years

• Peripheral vasculopathy

  from enrollment to the end of treamtent at three years

Study Arms (2)

Colchicine treatment

ACTIVE COMPARATOR

after randomization, a 0.5 mg tablet of colchicine per day will be administered.

Drug: colchicine treatment in chronic kidney disease patients

placebo treatment

PLACEBO COMPARATOR

after randomization 0,25 mg of placebo per day will be administered

Drug: placebo treatment

Interventions

colchicine treatment in chronic kidney disease patients DRUG

colchicine treatment 0.5 mg/day

Colchicine treatment

placebo treatment DRUG

placebo treatment 1 pill/day

placebo treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• 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.
• Chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
• 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:
• Other contraceptive methods (sexual abstinence, barrier methods, spermicides, etc.) are not considered acceptable for participation in this study
• Gastric ulcer
• History of aplastic anemia diagnosed through bone marrow biopsy.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28028, Spain

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 31, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)