Actively Recruiting

Phase 3
Age: 18Years - 99Years
All Genders
NCT06998862

Colchicine in Chronic Kidney Disease Patients

Led by Hospital General Universitario Gregorio Marañon · Updated on 2025-05-31

744

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Colchicine in Chronic Kidney Disease Patients

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 99 years
  • Moderate chronic kidney disease with eGFR between 30 and 59 mL/min/1.73 m2
  • History of previous cardiovascular event such as acute coronary syndrome, angina hospitalization, transient ischemic attack, non-cardioembolic ischemic stroke, coronary revascularization, or peripheral vasculopathy
  • Evidence of coronary artery disease on imaging test
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to colchicine or its excipients
  • Current colchicine treatment or use within the month prior to inclusion
  • Hospital admission within 3 months prior to inclusion
  • Active malignant cancer except non-melanoma skin cancer or carcinoma in situ
  • Uncontrolled or symptomatic chronic inflammatory disease
  • Active hepatitis B, hepatitis C, or HIV infection
  • Liver cirrhosis grade B or C
  • Immunosuppressive treatment within 12 weeks prior to inclusion
  • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Poorly controlled hypertension (>160/90 mmHg)
  • Pregnancy or breastfeeding; women of reproductive age must use effective contraception until 8 weeks after study ends
  • History of gastric ulcer
  • Thrombocytopenia (<50,000 cells/µL) within month prior to inclusion
  • Neutropenia (<1500 cells/mcL) within month prior to inclusion
  • Anemia (hemoglobin <10.5 g/dL) within month prior to inclusion
  • History of aplastic anemia diagnosed by bone marrow biopsy
  • Treatment with CYP3A4 or P-glycoprotein inhibitors within month prior to inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain, 28028

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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