Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2024-10-05
2026-12-31
Brief Summary
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Detailed Description
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Secondary objectives
* To evaluate the efficacy of INM004 in the reduction of mortality.
* To evaluate the efficacy of INM004 in the prevention and reduction of extrarenal complications.
* To evaluate the efficacy of INM004 in the improvement of TMA laboratory parameters.
* To evaluate the efficacy of INM004 in the reduction of hospital stay days.
* To evaluate the safety of INM004
* To evaluate the pharmacokinetics of INM004
* To evaluate the kinetics of Stx
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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INM004
Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragment at a dosage of 4 mg/kg of body weight, 24 hours apart.
INM004
Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments at a dosage of 4 mg/kg of body weight, 24 hours apart. Each vial contains 25 mg of protein/ml. Therefore, each subject must receive 0.16 ml/kg per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
Placebo
Two doses of saline solution, 24 hours apart.
Placebo
Two doses of placebo, 24 hours apart. The placebo solution has the same composition of excipients as INM004 without the active pharmaceutical ingredient, and its appearance is identical. Each subject must receive 0.16 ml/kg of placebo solution per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
Interventions
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INM004
Two doses of Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin F(ab´)2 fragments at a dosage of 4 mg/kg of body weight, 24 hours apart. Each vial contains 25 mg of protein/ml. Therefore, each subject must receive 0.16 ml/kg per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
Placebo
Two doses of placebo, 24 hours apart. The placebo solution has the same composition of excipients as INM004 without the active pharmaceutical ingredient, and its appearance is identical. Each subject must receive 0.16 ml/kg of placebo solution per dose. The vial volume will be reconstituted in a 100 ml (for subjects with a body weight of 20 kg or more) or 50 ml (for subjects under 20 kg of body weight) infusion bag. It will be administered as an intravenous infusion using an infusion pump over a period of 50 minutes. In subjects with a BMI over 30 kg/m2, infusion will be performed over a period of 100 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
9 Months
17 Years
ALL
No
Sponsors
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Exeltis
INDUSTRY
Chemo Research
INDUSTRY
Linical
UNKNOWN
KLIXAR
UNKNOWN
Inmunova S.A.
OTHER
Responsible Party
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Principal Investigators
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Santiago Sanguineti, Ph.D
Role: STUDY_DIRECTOR
Inmunova S.A.
Locations
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Hospital Interzonal Dr. José Penna
Bahía Blanca, Buenos Aires, Argentina
Hospital Penna
Bahía Blanca, Buenos Aires, Argentina
Hospital de niños Sor María Ludovica
La Plata, Buenos Aires, Argentina
Clinica del niño y la madre
Mar del Plata, Buenos Aires, Argentina
Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti
Mar del Plata, Buenos Aires, Argentina
Sanatorio de la Trinidad Ramos Mejia
Ramos Mejía, Buenos Aires, Argentina
Hospital El Cruce
San Juan Bautista, Buenos Aires, Argentina
Sanatorio Güemes
Buenos Aires, Buenos Aires F.D., Argentina
Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan"
Buenos Aires, Buenos Aires F.D., Argentina
Hospital General de Niños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Anchorena
CABA, Buenos Aires F.D., Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, Córdoba Province, Argentina
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province, Argentina
Hospital "San Antonio de Padua" Río Cuarto
Río Cuarto, Córdoba Province, Argentina
Hospital Pediátrico Dr. Humberto Notti
Mendoza, Mendoza Province, Argentina
Hospital Teodoro J. Schestakow
San Rafael, Mendoza Province, Argentina
Clínica Pediátrica San Lucas
Neuquén, Neuquén Province, Argentina
Hospital Público Materno Infantil
Salta, Salta Province, Argentina
Hospital Pediátrico San Luis
San Luis, San Luis Province, Argentina
Hospital de Niños Zona Norte "Dr. Roberto M. Carra"
Rosario, Santa Fe Province, Argentina
Sanatorio de Niños
Rosario, Santa Fe Province, Argentina
Hospital De Clínicas Pte. Nicolás Avellaneda
San Miguel de Tucumán, Tucumán Province, Argentina
Clínica Zabala
Ciudad Autonoma de Buenos Aire, , Argentina
Hospital de Niños Dr. Ricardo Gutierrez
Ciudad Autonoma de Buenos Aire, , Argentina
Sanatorio Allende
Córdoba, , Argentina
Cliniques universitaires Saint-Luc
Brussels, , Belgium
CHU De Bordeaux
Bordeaux, , France
Hospices Civils De Lyon - Hopital Femme Mere Enfant
Lyon, , France
Centre Hospitalier Universitaire De Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
Hospital Necker Enfants Malades
Paris, , France
Robert Debre University Hospital
Paris, , France
Trousseau Hospital
Paris, , France
CHU Rouen
Rouen, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
University Hospital Cologne AöR
Cologne, , Germany
Universitaetsklinikum Heidelberg AöR
Heidelberg, , Germany
Children's Health Ireland
Dublin, , Ireland
University Hospital Consorziale Policlinico
Bari, , Italy
IRCCS Sant'Orsola
Bologna, , Italy
Istituto Gianina Gaslini
Genova, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedale Università
Padua, , Italy
Spitalul Clinic de Urgenta pentru Copii Marie Sklodowska Curie
Bucharest, , Romania
Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu
Timișoara, , Romania
Hospital Universitario De Cruces
Barakaldo, , Spain
Hospital Infantil Universitario Niño Jesus
Madrid, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Royal Hospital for Sick Children
Glasgow, , United Kingdom
Great Ormon Street Hospital for Children
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CT-INM004-04
Identifier Type: -
Identifier Source: org_study_id
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