protocolSection identificationModule nctId: NCT06389474, orgStudyIdInfo id: CT-INM004-04, briefTitle: A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-16, primaryCompletionDateStruct date: 2025-07-28, completionDateStruct date: 2025-09-28, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Inmunova S.A., class: OTHER, collaborators name: KLIXAR, collaborators name: Chemo Research, collaborators name: Linical, collaborators name: Crovelis, descriptionModule briefSummary: 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)., conditionsModule conditions: Hemolytic-Uremic Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results), primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: INM004, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time to recovery of renal function during the acute phase, secondaryOutcomes measure: Short-term recovery of renal function, secondaryOutcomes measure: MAKE 90, secondaryOutcomes measure: Dialysis longer than 10 days, secondaryOutcomes measure: Dialysis requirement, secondaryOutcomes measure: Mortality, otherOutcomes measure: CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories, otherOutcomes measure: Evolution of renal function at 7 days (GFR_AUC1-7), otherOutcomes measure: Evolution of renal function at 28 days (GFR_AUC1-28), otherOutcomes measure: Evolution of renal function at 90 days (GFR_AUC1-90), otherOutcomes measure: Incidence of anuria, otherOutcomes measure: Extrarenal composite endpoint, otherOutcomes measure: Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia, otherOutcomes measure: Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia, otherOutcomes measure: Duration of hospitalization, otherOutcomes measure: Incidence of adverse events of special interest, otherOutcomes measure: Incidence of adverse events, otherOutcomes measure: Pharmacokinetic - AUC0-t, otherOutcomes measure: Pharmacokinetic - AUC0-inf, otherOutcomes measure: Pharmacokinetic - Cmax, otherOutcomes measure: Pharmacokinetic - Tmax, otherOutcomes measure: Pharmacokinetic - λz, otherOutcomes measure: Pharmacokinetic - t1/2, otherOutcomes measure: Pharmacokinetic - Vz, otherOutcomes measure: Pharmacokinetic - Cl, otherOutcomes measure: Pharmacokinetic - AUC/dose, otherOutcomes measure: Pharmacokinetic - Cmax/dose, otherOutcomes measure: Baseline Shiga toxin serum levels, otherOutcomes measure: Kinetics of Shiga toxin in serum, eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital El Cruce - Néstor Kirchner, city: Florencio Varela, state: Buenos Aires, country: Argentina, geoPoint lat: -34.82722, lon: -58.39556, locations facility: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti, city: Mar Del Plata, state: Buenos Aires, country: Argentina, geoPoint lat: -38.00228, lon: -57.55754, locations facility: Sanatorio de Niños, city: Rosario, state: Santa Fe, country: Argentina, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Clínica Zabala, city: Ciudad Autonoma de Buenos Aire, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Hospital de Niños Dr. Ricardo Gutierrez, city: Ciudad Autonoma de Buenos Aire, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Hospital de Niños de la Santísima Trinidad, city: Córdoba, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Sanatorio Allende, city: Córdoba, country: Argentina, geoPoint lat: -31.4135, lon: -64.18105, locations facility: Hospital Pediátrico Dr. Humberto Notti, city: Mendoza, country: Argentina, geoPoint lat: -32.89084, lon: -68.82717, hasResults: False