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New antitoxin aims to speed kidney recovery in kids with e. coli infection

NCT ID NCT06389474

Disease control Sponsor: Inmunova S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called INM004 in 220 children with hemolytic uremic syndrome (HUS) caused by E. coli bacteria. The goal is to see if it helps the kidneys recover faster and reduces the need for dialysis. Participants are children aged 9 months to 18 years who have confirmed STEC infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

9 months to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

hemolytic-uremic syndrome Shiga toxin-associated hemolytic uremic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemolytic-uremic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedale Università

    NOT_YET_RECRUITING

    Padova, Italy

  • Bristol Royal Hospital for Children

    NOT_YET_RECRUITING

    Bristol, United Kingdom

  • CHU De Bordeaux

    ACTIVE_NOT_RECRUITING

    Bordeaux, France

  • CHU Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • CHU Rouen

    NOT_YET_RECRUITING

    Rouen, France

  • Centre Hospitalier Universitaire De Montpellier

    ACTIVE_NOT_RECRUITING

    Montpellier, France

  • Charité - Universitätsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, Germany

  • Children's Health Ireland

    ACTIVE_NOT_RECRUITING

    Dublin, Ireland

  • Clinica del niño y la madre

    RECRUITING

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Cliniques universitaires Saint-Luc

    ACTIVE_NOT_RECRUITING

    Brussels, Belgium

  • Clínica Pediátrica San Lucas

    SUSPENDED

    Neuquén, Neuquén Province, 8300, Argentina

  • Clínica Zabala

    ACTIVE_NOT_RECRUITING

    Ciudad Autonoma de Buenos Aire, Argentina

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Italy

  • Great Ormon Street Hospital for Children

    NOT_YET_RECRUITING

    London, United Kingdom

  • Hospices Civils De Lyon - Hopital Femme Mere Enfant

    RECRUITING

    Lyon, France

  • Hospital "San Antonio de Padua" Río Cuarto

    RECRUITING

    Río Cuarto, Córdoba Province, 5806, Argentina

  • Hospital De Clínicas Pte. Nicolás Avellaneda

    ACTIVE_NOT_RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4001, Argentina

  • Hospital El Cruce

    NOT_YET_RECRUITING

    San Juan Bautista, Buenos Aires, Argentina

  • Hospital General de Niños Pedro de Elizalde

    ACTIVE_NOT_RECRUITING

    Buenos Aires, Buenos Aires F.D., 1270, Argentina

  • Hospital Infantil Universitario Niño Jesus

    RECRUITING

    Madrid, Spain

  • Hospital Interzonal Dr. José Penna

    NOT_YET_RECRUITING

    Bahía Blanca, Buenos Aires, 8000, Argentina

  • Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti

    RECRUITING

    Mar del Plata, Buenos Aires, Argentina

  • Hospital Necker Enfants Malades

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Hospital Pediátrico Dr. Humberto Notti

    RECRUITING

    Mendoza, Mendoza Province, Argentina

  • Hospital Pediátrico San Luis

    RECRUITING

    San Luis, San Luis Province, 5700, Argentina

  • Hospital Penna

    NOT_YET_RECRUITING

    Bahía Blanca, Buenos Aires, Argentina

  • Hospital Privado Centro Médico de Córdoba

    RECRUITING

    Córdoba, Córdoba Province, 5016, Argentina

  • Hospital Público Materno Infantil

    RECRUITING

    Salta, Salta Province, 4400, Argentina

  • Hospital Teodoro J. Schestakow

    RECRUITING

    San Rafael, Mendoza Province, 5600, Argentina

  • Hospital Universitario 12 De Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario De Cruces

    RECRUITING

    Barakaldo, Spain

  • Hospital de Niños Dr. Ricardo Gutierrez

    RECRUITING

    Ciudad Autonoma de Buenos Aire, Argentina

  • Hospital de Niños Zona Norte "Dr. Roberto M. Carra"

    RECRUITING

    Rosario, Santa Fe Province, 2013, Argentina

  • Hospital de Niños de la Santísima Trinidad

    RECRUITING

    Córdoba, Córdoba Province, Argentina

  • Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1245, Argentina

  • Hospital de niños Sor María Ludovica

    RECRUITING

    La Plata, Buenos Aires, 1900, Argentina

  • IRCCS Sant'Orsola

    NOT_YET_RECRUITING

    Bologna, Italy

  • Istituto Gianina Gaslini

    RECRUITING

    Genova, Italy

  • Robert Debre University Hospital

    RECRUITING

    Paris, France

  • Royal Hospital for Sick Children

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Sanatorio Allende

    WITHDRAWN

    Córdoba, Argentina

  • Sanatorio Anchorena

    ACTIVE_NOT_RECRUITING

    CABA, Buenos Aires F.D., 1425, Argentina

  • Sanatorio Güemes

    ACTIVE_NOT_RECRUITING

    Buenos Aires, Buenos Aires F.D., 1188, Argentina

  • Sanatorio de Niños

    RECRUITING

    Rosario, Santa Fe Province, Argentina

  • Sanatorio de la Trinidad Ramos Mejia

    NOT_YET_RECRUITING

    Ramos Mejía, Buenos Aires, Argentina

  • Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca

    RECRUITING

    Cluj-Napoca, Romania

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu

    NOT_YET_RECRUITING

    Timișoara, Romania

  • Spitalul Clinic de Urgenta pentru Copii Marie Sklodowska Curie

    NOT_YET_RECRUITING

    Bucharest, Romania

  • Trousseau Hospital

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Universitaetsklinikum Heidelberg AöR

    RECRUITING

    Heidelberg, Germany

  • University Hospital Cologne AöR

    NOT_YET_RECRUITING

    Cologne, Germany

  • University Hospital Consorziale Policlinico

    RECRUITING

    Bari, Italy

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Other studies related to the condition(s) this trial covers.