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Treatment of Hemolytic Uremic Syndrome in Children with INM004

A Phase III Study to Evaluate the Efficacy of INM004 (Shiga Antitoxin) in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome.

Phase 3 Interventional Inmunova S.A. · NCT06389474

This study is testing if adding a new treatment called INM004 to standard care can help children with Hemolytic Uremic Syndrome caused by E. coli recover better and faster.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment220 (estimated)
Ages9 Months to 17 Years
SexAll
SponsorInmunova S.A. Academic / other
Locations52 sites (Bahía Blanca, Buenos Aires and 51 other locations)
Trial IDNCT06389474 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients suffering from Hemolytic Uremic Syndrome (STEC-HUS) caused by Shiga toxin-producing Escherichia coli. The primary goal is to assess how well INM004, when added to standard care, improves renal function. Secondary objectives include reducing mortality, preventing extrarenal complications, and shortening hospital stays. The study involves a randomized, controlled design comparing INM004 to a placebo.

Who should consider this trial

Good fit: Ideal candidates are children aged 9 months to 18 years diagnosed with STEC-HUS and hospitalized for treatment.

Not a fit: Patients who do not have a confirmed STEC infection or are outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve renal function and reduce complications in children with STEC-HUS.

How similar studies have performed: While there have been studies on treatments for STEC-HUS, the specific approach with INM004 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 9 months and \< 18 years at the time of randomization.
2. In addition, only for subjects \< 1 year and ≥ 15 years, confirmation of STEC infection determined by:

   1. Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
   2. Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
   3. Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
   4. Fecal culture positive for E. coli O157 confirmed by serogroup-specific seroagglutination.
3. Hospitalization at the participating institution.
4. History of onset of diarrhea within 10 days prior to STEC-HUS diagnosis at the participating institution.
5. Diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis, and platelet consumption:

   1. Signs of renal damage defined as:

      * Serum creatinine value above the ULN for age and sex, and GFR below the LLN for age, sex, and height.
   2. Presence of hemolysis documented by:

      * LDH levels above the ULN for age, and/or
      * Presence of schistocytes in peripheral blood smear.
   3. Platelet consumption according to any of the following laboratory criteria:

      * Peripheral blood platelet count \< 150 × 103/μL, and/or
      * A ≥50% decrease in peripheral blood platelet count compared to a sample collected within the previous 24 hours.
6. Informed consent form signed and dated by the subject or, the legal guardian(s), with the subject's assent as appropriate based on age and regulatory guidelines in the region.
7. Subjects who have already had menarche must have a negative pregnancy test.

Exclusion Criteria:

1. Start of dialysis within 48 hours prior to admission to the participating institution.
2. More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
3. History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
4. Personal and/or family history of atypical HUS.
5. Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
6. Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
7. Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the study medication.
8. History of: a) anaphylaxis of any kind; b) prior administration of equine serum (e.g., antivenom, anti-arachnid serum, anti-SARS-CoV-2 serum, etc.) or an allergic reaction from contact or exposure to horses.
9. Pregnant or breastfeeding woman.
10. Impossibility of hospitalization in the participating institution.
11. Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
12. Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines.
13. Medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs:

    * Congenital or acquired anomalies that may affect functioning renal mass.
    * Epilepsy or structural abnormalities of the brain that may increase the risk of seizures.
    * Trisomy 21.
    * Prematurity (born before 28 weeks gestation).
    * Other (according to investigator criteria).

Where this trial is running

Bahía Blanca, Buenos Aires and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hemolytic-Uremic SyndromeSTEC-HUSTypical Hemolytic Uremic SyndromeDiarrhea asociated-Hemolytic Uremic SyndromeShiga toxin-producing Escherichia coliShiga toxin
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.