Hemolytic-Uremic Syndrome Clinical Trial
Official title:
A Phase III Study to Evaluate the Efficacy of INM004 (Shiga Antitoxin) in Pediatric Patients With Shiga Toxin-producing Escherichia Coli-associated Hemolytic Uremic Syndrome.
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 ;
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