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Study on Colchicine and Opium for Preventing Heart and Kidney Issues in Patients with Moderate Chronic Kidney Disease

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called colchicine in patients with chronic kidney disease. Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste from the blood. The study aims to see if taking a low dose of colchicine daily can help prevent further heart and blood vessel problems, as well as slow down the progression of kidney disease in these patients.

Participants in the study will receive either colchicine or a placebo. The study will monitor the occurrence of heart-related events such as heart attacks, strokes, and other issues that might require hospitalization or surgery. It will also look at how the kidneys are functioning over time, checking for any significant changes in kidney health. The study will last for a period of time, during which participants will be regularly assessed to track their health and any changes that occur.

The goal is to determine if colchicine can be beneficial in reducing the risk of serious heart and kidney problems in people with moderate chronic kidney disease. This research could provide valuable insights into new ways to manage and treat this condition, potentially improving the quality of life for those affected.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age and medical history related to chronic kidney disease and previous cardiovascular events.

  2. Step 2

    Medication administration

    The study involves the administration of colchicine, a medication taken orally.

    The dosage is 0.5 mg per day and is intended to be taken consistently throughout the study period.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to assess the incidence of cardiovascular events such as heart attacks, strokes, and other related conditions.

    The study also evaluates the progression of kidney disease by measuring changes in kidney function and other health markers.

  4. Step 4

    End of study

    The study is expected to conclude by July 2027.

    Final assessments will be conducted to evaluate the overall effectiveness of the treatment in preventing cardiovascular events and slowing kidney disease progression.

Who can join the trial?

9 criteria

  • Must be between 18 and 99 years old.
  • Have **moderate chronic kidney disease**, which means the kidneys are not working as well as they should. This is measured by a test called the **glomerular filtration rate** (GFR), which should be between 30 and 59.
  • Have a history of a previous **cardiovascular event**, which includes:
    • **Acute coronary syndrome**, a condition where the heart doesn't get enough blood.
    • Being admitted to the hospital for **angina pectoris**, which is chest pain due to reduced blood flow to the heart.
    • Having a **transient ischemic attack** (a temporary blockage of blood flow to the brain) or a **non-cardioembolic ischemic stroke** (a type of stroke not caused by a heart problem).
    • Undergoing **coronary revascularization**, a procedure to restore blood flow to the heart.
    • Having **peripheral vasculopathy**, which includes problems with blood flow in the arms or legs, such as an **embolism** (a blockage) or **ischemia** (lack of blood flow), or needing an **amputation** or a procedure called **percutaneous surgical revascularization** to improve blood flow.
    • Finding of **coronary artery disease** on an imaging test, which shows problems with the blood vessels that supply the heart.
    • Must have the legal ability and willingness to sign a document called **informed consent**, which means agreeing to participate in the study after understanding what it involves.

Who cannot join the trial?

3 criteria

  • Patients with chronic renal disease cannot participate. This means if you have long-term kidney problems, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The study is looking for people in certain age groups.
  • Patients who are part of a vulnerable population cannot participate. This means if you are in a group that needs special protection, you are not eligible.
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Investigated drugs

Colchicine is a medication being studied for its potential to prevent further vascular events and slow down the progression of kidney disease in patients with moderate chronic kidney disease. It is being tested to see if it can reduce the risk of serious heart-related problems, such as heart attacks, strokes, and other issues that might require hospitalization or surgery. The study is exploring whether taking colchicine can help improve the health outcomes for these patients by reducing the likelihood of these events occurring.

What is already known about the treatment

Colchicine – Colchicine is administered orally in tablet form, typically at a low dose of 0.5 mg per day. It is currently being studied for its potential benefits in preventing cardiovascular events and slowing the progression of chronic kidney disease. The main therapeutic indications include secondary prevention of vascular events such as heart attacks and strokes in patients with moderate chronic renal disease. At the molecular level, colchicine works by disrupting microtubule formation, which affects various cellular processes, including inflammation. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. In more advanced stages, complications like high blood pressure, anemia, and bone disease may occur. The progression of chronic kidney disease can vary, with some people experiencing a slow decline in kidney function, while others may see a more rapid deterioration. Regular monitoring and lifestyle adjustments are often necessary to manage the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505868-11-00Protocol codeFIBHGM-ECNC002-2022Estimated enrolment744 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

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