Efficacy of INM004 in Children With STEC-HUS

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hemolytic-Uremic Syndrome

In brief

The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).

Key facts

Study ID

NCT06389474

Run by

Inmunova S.A.

People needed

220

Starts

2024-10-05

Expected to finish

2026-12-31

Last updated by the study team

2026-01-15

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 9 months and < 18 years at the time of randomization.
• In addition, only for subjects < 1 year and ≥ 15 years, confirmation of STEC infection determined by:
• Detection of generic Stx, Stx1, Stx2, or Stx1/Stx2 in stools by enzyme immunoassay (EIA); or
• Detection of stx, stx1, stx2, or stx1/stx2 genes in stools by Polymerase Chain Reaction (PCR); or
• Detection of specific anti-polysaccharide (IgM) antibodies in serum; or
• Fecal culture positive for E. coli O157 confirmed by serogroup-specific seroagglutination.
• Hospitalization at the participating institution.
• History of onset of diarrhea within 10 days prior to STEC-HUS diagnosis at the participating institution.
• Diagnosis of STEC-HUS defined as a subject with signs of renal damage, hemolysis, and platelet consumption:
• 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.
• Presence of hemolysis documented by:
• LDH levels above the ULN for age, and/or
• Presence of schistocytes in peripheral blood smear.
• 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.
• 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.
• Subjects who have already had menarche must have a negative pregnancy test.

You may not qualify if…

• Start of dialysis within 48 hours prior to admission to the participating institution.
• More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
• History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
• Personal and/or family history of atypical HUS.
• Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
• Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
• 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.
• 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.
• Pregnant or breastfeeding woman.
• Impossibility of hospitalization in the participating institution.
• Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
• Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines.
• 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 it is running

• Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca — Cluj-Napoca, Romania (enrolling)
• Hospital Universitario 12 De Octubre — Madrid, Spain (enrolling)
• Robert Debre University Hospital — Paris, France (enrolling)
• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
• Hospital Universitario De Cruces — Barakaldo, Spain (enrolling)
• Hospital Infantil Universitario Niño Jesus — Madrid, Spain (enrolling)
• Hospices Civils De Lyon - Hopital Femme Mere Enfant — Lyon, France (enrolling)
• Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan" — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
• Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Istituto Gianina Gaslini — Genova, Italy (enrolling)
• Hospital de niños Sor María Ludovica — La Plata, Buenos Aires, Argentina (enrolling)
• Hospital de Niños de la Santísima Trinidad — Córdoba, Córdoba Province, Argentina (enrolling)
• Hospital "San Antonio de Padua" Río Cuarto — Río Cuarto, Córdoba Province, Argentina (enrolling)
• Hospital Pediátrico Dr. Humberto Notti — Mendoza, Mendoza Province, Argentina (enrolling)
• Hospital Teodoro J. Schestakow — San Rafael, Mendoza Province, Argentina (enrolling)
• Clinica del niño y la madre — Mar del Plata, Buenos Aires, Argentina (enrolling)
• Hospital Público Materno Infantil — Salta, Salta Province, Argentina (enrolling)
• Hospital Pediátrico San Luis — San Luis, San Luis Province, Argentina (enrolling)
• Hospital de Niños Zona Norte "Dr. Roberto M. Carra" — Rosario, Santa Fe Province, Argentina (enrolling)
• Sanatorio de Niños — Rosario, Santa Fe Province, Argentina (enrolling)
• Universitaetsklinikum Heidelberg AöR — Heidelberg, Germany (enrolling)
• University Hospital Consorziale Policlinico — Bari, Italy (enrolling)
• Hospital de Niños Dr. Ricardo Gutierrez — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• Hospital Privado Centro Médico de Córdoba — Córdoba, Córdoba Province, Argentina (enrolling)
• Royal Hospital for Sick Children — Glasgow, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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