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

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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 a condition called Hemolytic Uremic Syndrome, which is associated with an infection caused by a type of bacteria known as Shiga toxin-producing Escherichia coli. This condition can lead to serious kidney problems, especially in children. The study is testing a treatment called INM004, also known as Shiga antitoxin, which is designed to target and neutralize the harmful effects of the Shiga toxin produced by the bacteria. The treatment is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to evaluate how effective INM004 is in improving kidney function in children affected by this condition. Participants in the study will receive either the INM004 treatment or a placebo, which is a solution that looks like the treatment but does not contain the active substance. The study will monitor the participants over a period to see how their kidney function recovers, particularly focusing on the time it takes for their kidneys to start working properly again without the need for dialysis, a process that helps clean the blood when the kidneys are not functioning well.

Throughout the study, researchers will also look at other important outcomes, such as the overall recovery of kidney function after three months, the need for extended dialysis, and the general health of the participants. The study aims to provide valuable information on whether INM004 can be a beneficial treatment for children suffering from Hemolytic Uremic Syndrome due to Shiga toxin-producing Escherichia coli.

The research process

The trial runs in 5 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 age and specific health criteria related to Hemolytic Uremic Syndrome (HUS) caused by Shiga toxin-producing Escherichia coli.

    Informed consent is required from the patient or their legal guardian.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the clinical diagnosis of HUS, which includes signs of kidney damage, hemolysis, and low platelet count.

    Tests may include blood tests and stool samples to detect the presence of Shiga toxin.

  3. Step 3

    Treatment administration

    The treatment involves the administration of ANTI SHIGA TOXIN through an intravenous infusion. This is a solution containing equine immunoglobulin fragments targeting Shiga toxin.

    A placebo, which is a sterile saline solution, may also be administered for comparison.

  4. Step 4

    Monitoring and follow-up

    Patients are monitored for recovery of kidney function during the acute phase, with a focus on achieving normal levels of kidney function indicators within 28 days.

    Regular follow-ups are conducted to assess kidney function at 90 days, including the need for dialysis and overall health outcomes.

  5. Step 5

    Completion of the study

    The study is expected to conclude by October 2026, with all data collected and analyzed to evaluate the efficacy of the treatment.

Who can join the trial?

12 criteria

  • Must be older than 9 months and younger than 18 years at the time of joining the study.
  • If younger than 1 year or 15 years and older, must have confirmation of a specific infection called **STEC**. This can be confirmed by:
    • Finding certain substances (Stx, Stx1, Stx2) in stool using a special test called enzyme immunoassay (EIA).
    • Finding specific genes (stx, stx1, stx2) in stool using a test called Polymerase Chain Reaction (PCR).
    • Finding specific antibodies (IgM) in blood or serum.
    • Having a stool culture that is positive for a type of bacteria called **E. coli O157**.
    • Must be hospitalized at the participating institution.
    • Must have had diarrhea within 10 days before being diagnosed with **STEC-HUS** at the participating institution.
    • Must have a clinical diagnosis of **STEC-HUS**, which includes:
      • Signs of kidney damage, such as high levels of a substance called creatinine in the blood or low kidney function (GFR).
      • Signs of hemolysis, which means the breakdown of red blood cells, shown by high levels of a substance called LDH or the presence of broken red blood cells (schistocytes) in a blood test.
      • Low platelet count, which are cells that help with blood clotting, shown by a count less than 150,000 per microliter or a significant drop in platelet count compared to a previous test.
      • Must have a signed and dated informed consent form, either by the participant or their legal guardian, with the participant's agreement if appropriate for their age.
      • If the participant is a female who has started menstruating, they must have a negative pregnancy test.

Who cannot join the trial?

8 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an allergic reaction to similar treatments in the past.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients with certain infections that could affect the study results.
  • Patients who have received certain medications recently that might interfere with the study.
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Investigated drugs

INM004 is a medication being studied for its ability to help children with Hemolytic Uremic Syndrome, a condition that affects the kidneys and is associated with an infection caused by Shiga toxin-producing Escherichia coli. This medication is designed to act as an antitoxin, which means it works to neutralize the harmful effects of the Shiga toxin in the body. The goal of using INM004 in this study is to see if it can improve kidney function when added to the standard care that patients are already receiving.

What is already known about the treatment

INM004 – INM004 is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating Hemolytic Uremic Syndrome, particularly in children affected by Shiga toxin-producing Escherichia coli. The medication is in the Phase III stage of clinical trials, indicating it is being evaluated for safety and efficacy before potential approval for general medical use. INM004 works by neutralizing the Shiga toxin, which is responsible for causing damage to the kidneys and other organs. It is classified as a biological antitoxin, specifically targeting bacterial toxins to prevent further harm to the body.

Investigated diseases

Hemolytic Uremic Syndrome – This condition is characterized by the destruction of red blood cells, which can lead to kidney failure. It often begins with symptoms such as diarrhea, abdominal pain, and vomiting, followed by a decrease in urine output. As the disease progresses, it can cause fatigue, high blood pressure, and swelling due to fluid retention. The syndrome is most commonly triggered by an infection, particularly with certain strains of bacteria like E. coli. In severe cases, it can affect other organs, leading to complications such as neurological symptoms. The condition is considered rare and requires careful monitoring of kidney function.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-512412-22-00Protocol codeCT-INM004-04Estimated enrolment347 patientsSponsorChemo Research S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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