#1 Clinical Trials Search in Europe

Opium, Standardized Powdered

This article discusses a clinical trial investigating the use of a medication containing opium, standardized powdered, along with colchicine, for patients with moderate chronic kidney disease. The study aims to evaluate the effectiveness of this treatment in preventing cardiovascular events and slowing the progression of kidney disease. We’ll explore the trial’s objectives, eligibility criteria, and potential outcomes for patients with this condition.

Table of Contents

What is Opium, Standardized Powdered?

Opium, Standardized Powdered is a medicinal substance derived from the opium poppy plant. It is standardized, which means it has a consistent and controlled amount of active ingredients. In the context of this study, it is being used in combination with another medication called colchicine[1].

Medical Use in Chronic Kidney Disease

The study is investigating the use of opium, standardized powdered, along with colchicine, in patients with moderate chronic kidney disease. Chronic kidney disease is a condition where the kidneys gradually lose their function over time[1].

The main goal of this research is to see if this combination can help prevent:

  • Cardiovascular events: These are problems related to the heart and blood vessels, such as heart attacks or strokes.
  • Renal progression: This refers to the worsening of kidney disease over time[1].

Study Details

The study, known as the COLCHIREN study, is looking at the effectiveness of a low dose (0.5 mg per day) of colchicine combined with opium, standardized powdered. It aims to prevent several types of cardiovascular events in patients with moderate chronic kidney disease, including:

  • Cardiovascular death
  • Acute coronary syndrome (a term for conditions where blood flow to the heart is suddenly reduced)
  • Angina requiring hospitalization (chest pain due to reduced blood flow to the heart)
  • Coronary revascularization (procedures to restore blood flow to the heart)
  • Transient ischemic attack or non-cardioembolic ischemic stroke (types of “mini-strokes”)
  • Peripheral vasculopathy (problems with blood vessels outside the heart and brain)[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:

  • Age between 18 and 99 years
  • Moderate chronic kidney disease (with specific measures of kidney function)
  • History of a previous cardiovascular event

There are also several exclusion criteria, which include:

  • Allergy or intolerance to colchicine
  • Current or recent treatment with colchicine
  • Recent hospital admission
  • Active cancer
  • Uncontrolled chronic inflammatory diseases
  • Certain infections or liver conditions
  • Pregnancy or breastfeeding[1]

Potential Benefits

The researchers hope that this treatment might:

  • Reduce the risk of future cardiovascular events in patients with moderate chronic kidney disease
  • Slow down the progression of kidney disease
  • Improve markers of inflammation and fibrosis (scarring) in the body[1]

Safety Considerations

As with any medical treatment, safety is a crucial concern. The study will carefully monitor for any side effects or adverse events. Some specific safety considerations include:

  • Avoiding use in patients with certain blood disorders (like low platelet count or anemia)
  • Caution in patients taking certain other medications that might interact with the study drug
  • Close monitoring of kidney function throughout the study[1]

It’s important to note that this is a research study, and the benefits and risks of this treatment are still being investigated. Patients should always consult with their healthcare provider before considering participation in any clinical trial.

Aspect Details
Study Name COLCHIREN Study
Main Medication Colchicine with Opium, Standardized Powdered
Dosage 0.5 mg/day
Target Condition Moderate Chronic Kidney Disease
Primary Goal Prevent cardiovascular events
Secondary Goals Slow kidney disease progression, evaluate effects on inflammation and fibrosis markers
Participant Age Range 18-99 years
Treatment Duration Up to 36 months
Key Exclusions Recent hospitalizations, active cancer, uncontrolled inflammatory diseases, pregnancy

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess if a low-dose colchicine treatment (0.5 mg/day) can help prevent cardiovascular events in patients with moderate chronic kidney disease. The trial also aims to evaluate its effect on kidney disease progression.
  • Who can participate in this clinical trial? Participants must be between 18 and 99 years old, have moderate chronic kidney disease (with specific kidney function criteria), and have a history of cardiovascular events. They must also be willing to sign informed consent.
  • What are some reasons someone might not be able to participate? Exclusion criteria include allergies to the medication, current colchicine treatment, recent hospital admission, active cancer, uncontrolled inflammatory diseases, certain viral infections, liver cirrhosis, and pregnancy or breastfeeding, among others.
  • What outcomes will the researchers measure? The primary outcome is the occurrence of cardiovascular events such as death from cardiovascular causes, acute coronary syndrome, and stroke. Secondary outcomes include individual cardiovascular events, kidney disease progression, and changes in inflammation and fibrosis markers.
  • How long does the treatment last in this trial? The maximum treatment period mentioned in the trial information is 36 months, which is equivalent to 3 years.

Ongoing Clinical Trials on Opium, Standardized Powdered

  • Study of colchicine to improve insulin sensitivity in adults with type 1 diabetes who have low-grade inflammation

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Managing Heart Attack Risk with Icosapent Ethyl and Drug Combination for Patients at High Risk of Another Heart Attack

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Poland

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

    Recruiting

    3 1 1
    Investigated drugs:
    Spain

  • Study on Colchicine and Tiemonium Methylsulphate for Reducing Atherosclerosis in Cancer Patients Undergoing Immune Therapy

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

References

  1. http://clinicaltrials.eu/trial/study-on-colchicine-and-opium-for-preventing-heart-and-kidney-issues-in-patients-with-moderate-chronic-kidney-disease/