nctId: NCT06389474 id: CT-INM004-04 briefTitle: A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2025-07-28 date: 2025-09-28 date: 2024-04-29 date: 2024-04-29 name: Inmunova S.A. class: OTHER name: KLIXAR name: Chemo Research name: Linical name: Crovelis 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). conditions: Hemolytic-Uremic Syndrome studyType: INTERVENTIONAL phases: PHASE3 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 masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: INM004 name: Placebo measure: Time to recovery of renal function during the acute phase measure: Short-term recovery of renal function measure: MAKE 90 measure: Dialysis longer than 10 days measure: Dialysis requirement measure: Mortality measure: CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories measure: Evolution of renal function at 7 days (GFR_AUC1-7) measure: Evolution of renal function at 28 days (GFR_AUC1-28) measure: Evolution of renal function at 90 days (GFR_AUC1-90) measure: Incidence of anuria measure: Extrarenal composite endpoint measure: Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia measure: Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia measure: Duration of hospitalization measure: Incidence of adverse events of special interest measure: Incidence of adverse events measure: Pharmacokinetic - AUC0-t measure: Pharmacokinetic - AUC0-inf measure: Pharmacokinetic - Cmax measure: Pharmacokinetic - Tmax measure: Pharmacokinetic - λz measure: Pharmacokinetic - t1/2 measure: Pharmacokinetic - Vz measure: Pharmacokinetic - Cl measure: Pharmacokinetic - AUC/dose measure: Pharmacokinetic - Cmax/dose measure: Baseline Shiga toxin serum levels measure: Kinetics of Shiga toxin in serum sex: ALL minimumAge: 9 Months maximumAge: 17 Years stdAges: CHILD facility: Hospital El Cruce - Néstor Kirchner city: Florencio Varela state: Buenos Aires country: Argentina lat: -34.82722 lon: -58.39556 facility: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti city: Mar Del Plata state: Buenos Aires country: Argentina lat: -38.00228 lon: -57.55754 facility: Sanatorio de Niños city: Rosario state: Santa Fe country: Argentina lat: -32.94682 lon: -60.63932 facility: Clínica Zabala city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños Dr. Ricardo Gutierrez city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños de la Santísima Trinidad city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Sanatorio Allende city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Hospital Pediátrico Dr. Humberto Notti city: Mendoza country: Argentina lat: -32.89084 lon: -68.82717 hasResults: False