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Equine Immunoglobulin F(Ab’)2 Fragments Targeting Shiga Toxin

This article discusses a Phase III clinical trial investigating the use of INM004, a drug containing Equine Immunoglobulin F(Ab’)2 Fragments Targeting Shiga Toxin, for treating children with Hemolytic Uremic Syndrome (HUS) caused by Shiga toxin-producing Escherichia coli (STEC). The study aims to assess the efficacy and safety of INM004 in improving renal function and reducing complications associated with STEC-HUS in pediatric patients.

Table of Contents

What is INM004?

INM004, also known as “ANTI SHIGA TOXIN” or “Shiga antitoxin,” is a new medication being studied for the treatment of a serious condition called Hemolytic Uremic Syndrome (HUS) in children[1]. The active ingredient in INM004 is equine immunoglobulin F(ab’)2 fragments targeting Shiga toxin. This means it’s made from parts of antibodies from horses that are specifically designed to fight against a toxin called Shiga toxin[1].

What is Hemolytic Uremic Syndrome (HUS)?

Hemolytic Uremic Syndrome (HUS) is a serious condition that can occur after an infection with certain types of E. coli bacteria that produce Shiga toxin. These bacteria are called Shiga toxin-producing Escherichia coli (STEC). HUS can cause damage to the kidneys and other organs[1]. It typically affects children and can be life-threatening if not treated promptly.

How INM004 Works

INM004 is designed to target and neutralize the Shiga toxin produced by certain E. coli bacteria. By doing this, it aims to reduce the harmful effects of the toxin on the body, particularly on the kidneys. The medication is given as an intravenous infusion, which means it’s delivered directly into the bloodstream through a vein[1].

Clinical Trial Details

A Phase III clinical trial is currently underway to evaluate how well INM004 works in children with HUS caused by Shiga toxin-producing E. coli[1]. Here are some key details about the trial:

  • It’s a randomized, double-blind, placebo-controlled study, which means some participants will receive INM004 while others will receive a placebo (a substance with no active medication).
  • The study aims to enroll about 220 participants.
  • Participants will be randomly assigned to receive either INM004 or a placebo.
  • The medication is given as two doses of 4 mg/kg, 24 hours apart[1].

Who Can Participate in the Trial?

The trial is looking for children who meet specific criteria. Some key points include:

  • Age: Children between 9 months and 18 years old[1].
  • Diagnosis: Must have a clinical diagnosis of STEC-HUS (HUS caused by Shiga toxin-producing E. coli)[1].
  • Recent symptoms: Must have had diarrhea within 10 days before being diagnosed with STEC-HUS[1].

There are also several conditions that would prevent a child from participating in the trial, such as certain medical conditions or recent participation in other clinical trials[1].

Potential Benefits of INM004

The researchers are studying INM004 to see if it can provide several benefits for children with HUS, including:

  1. Improving kidney function[1].
  2. Reducing the risk of death[1].
  3. Preventing or reducing complications in other organs[1].
  4. Improving blood-related issues associated with HUS[1].
  5. Reducing the length of hospital stay[1].

Safety Considerations

As with any new medication, safety is a crucial concern. The trial will carefully monitor the safety of INM004[1]. It’s important to note that because INM004 is made from horse antibodies, people with a history of allergic reactions to horses or horse-derived products are not eligible to participate in the trial[1].

This clinical trial represents an important step in developing a potential new treatment for children with HUS. If successful, INM004 could offer a new option for managing this serious condition.

Aspect Details
Study Type Phase III, multicenter, randomized, double-blind, adaptive-designed, placebo-controlled clinical trial
Medication INM004 (Equine Immunoglobulin F(Ab’)2 Fragments Targeting Shiga Toxin)
Condition Hemolytic Uremic Syndrome associated with Shiga toxin-producing Escherichia coli (STEC-HUS)
Target Population Children aged 9 months to 18 years
Primary Objective Evaluate efficacy in improving renal function
Secondary Objectives Assess impact on mortality, extrarenal complications, hematological parameters, hospital stay duration, and safety
Dosage Two doses of 4 mg/kg, administered 24 hours apart
Administration Route Intravenous infusion
Primary Endpoint Time to recovery of renal function during the acute phase (within 28 days)
Key Secondary Endpoints Recovery of kidney function at 90 days, incidence of dialysis, mortality rate

FAQ

  • What is INM004 and how does it work? INM004 is a drug containing Equine Immunoglobulin F(Ab')2 Fragments that target Shiga toxin. It works by neutralizing the toxin produced by certain strains of E. coli bacteria, which can cause Hemolytic Uremic Syndrome in children.
  • Who is eligible for this clinical trial? The trial is open to children between 9 months and 18 years old who have been diagnosed with STEC-HUS, have signs of renal damage, hemolysis, and platelet consumption, and meet other specific criteria outlined in the study protocol.
  • What are the main objectives of the study? The primary objective is to evaluate the efficacy of INM004 in improving renal function. Secondary objectives include assessing its impact on mortality, extrarenal complications, hematological parameters, hospital stay duration, and overall safety.
  • How is the drug administered in the trial? Participants in the experimental arm receive two doses of INM004 at 4 mg/kg, administered 24 hours apart through intravenous infusion.
  • What are the potential benefits of participating in this trial? Participants may benefit from a potentially effective treatment for STEC-HUS, which could lead to faster recovery of renal function, reduced complications, and shorter hospital stays. However, as with any clinical trial, there are no guarantees of benefits, and potential risks should be considered.

Ongoing Clinical Trials on Equine Immunoglobulin F(Ab’)2 Fragments Targeting Shiga Toxin

  • Study on the Effectiveness of INM004 for Children with Hemolytic Uremic Syndrome Caused by Shiga Toxin-Producing E. coli

    Recruiting

    3 1
    Investigated drugs:
    Belgium France Germany Ireland Italy The Netherlands +2

Glossary

  • Hemolytic Uremic Syndrome (HUS): A condition characterized by the destruction of red blood cells, low platelet count, and kidney failure, often caused by Shiga toxin-producing E. coli infection.
  • Shiga toxin: A poison produced by certain strains of bacteria, particularly some types of E. coli, that can cause severe damage to the body, especially the kidneys.
  • STEC-HUS: Hemolytic Uremic Syndrome caused specifically by Shiga toxin-producing Escherichia coli (STEC) infection.
  • Renal function: The ability of the kidneys to filter waste products from the blood and maintain proper fluid balance in the body.
  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood, used to assess kidney function.
  • Serum creatinine (sCr): A waste product in the blood that is normally filtered out by the kidneys. Elevated levels can indicate kidney problems.
  • Hemolysis: The breakdown or destruction of red blood cells, which can release hemoglobin into the bloodstream.
  • Thrombocytopenia: A condition characterized by abnormally low levels of platelets in the blood, which can lead to easy bruising and bleeding.
  • Dialysis: A medical procedure that filters waste products from the blood when the kidneys are not functioning properly.
  • Extrarenal complications: Health issues that occur outside of the kidneys as a result of the primary condition, in this case, STEC-HUS.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-inm004-for-children-with-hemolytic-uremic-syndrome-caused-by-shiga-toxin-producing-e-coli/