Study of INM004 Treatment in Children Ages 9 Months to 17 Years With Hemolytic Uremic Syndrome Caused by Shiga Toxin-Producing E. coli

What this Trial Is About

Researchers are evaluating the efficacy, safety, and pharmacokinetics of INM004 in children with Hemolytic Uremic Syndrome caused by Shiga toxin-producing Escherichia coli STEC-HUS. This study aims to assess how well INM004, when added to standard care, improves kidney function and reduces complications, mortality, and hospital stay in affected pediatric patients. Participants will be randomly assigned to receive either two doses of INM004, an Anti-Shiga Toxin Hyperimmune Equine Immunoglobulin fragment, or two doses of a placebo solution. Each dose is given intravenously 24 hours apart, with infusion times adjusted based on body mass index. The study includes a 28-day acute phase and further assessments up to 90 days to monitor recovery and other health outcomes. During the study, children will undergo evaluations of kidney function, blood tests for markers of disease activity, and safety assessments. Researchers will measure the time to kidney function recovery as the primary outcome, along with mortality rates, dialysis needs, and hospital stay length. The trial lasts for at least 90 days, including close monitoring of health status and medication effects throughout this period.

Efficacy of INM004 in Children With STEC-HUS