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).
The primary objective will be to evaluate the efficacy of INM004, added to the standard of care, as a treatment for STEC-HUS in the amelioration of renal function. 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
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
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
Bahía Blanca, Buenos Aires, Argentina
Bahía Blanca, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
San Juan Bautista, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
CABA, Buenos Aires F.D., Argentina
Córdoba, Córdoba Province, Argentina
Córdoba, Córdoba Province, Argentina
Río Cuarto, Córdoba Province, Argentina
Mendoza, Mendoza Province, Argentina
San Rafael, Mendoza Province, Argentina
Neuquén, Neuquén Province, Argentina
Salta, Salta Province, Argentina
San Luis, San Luis Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Ciudad Autonoma de Buenos Aire, Argentina
Córdoba, Argentina