Trial reportPediatric nephrology (Berlin, Germany)2025
Open-label, controlled, phase 2 clinical trial assessing the safety, efficacy, and pharmacokinetics of INM004 in pediatric patients with Shiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome.
Trial report in Pediatric nephrology (Berlin, Germany), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed.
- Serology as an early diagnostic tool in pediatric patients with Shiga toxin-producingJournal of clinical microbiology · 2026Trial
- Shiga toxin delivery in extracellular vesicles induces high mortality and severe kidney injury in a Gb3-dependent manner.PLoS pathogens · 2026Article
- Shiga toxin-centered pathophysiology defines the therapeutic limits of enterohemorrhagic Escherichia coli infection.Archives of microbiology · 2026Review
- Shiga toxin-centered pathophysiology defines the therapeutic limits of enterohemorrhagic Escherichia coli infection.Archives of microbiology · 2026Review
- Improving hemolytic uremic syndrome diagnosis in children: the role of serology for Shiga toxin-producing Escherichia coli detection.Pediatric nephrology (Berlin, Germany) · 2026Article
- Biological Profiling of Postbiotics of Lactobacillus plantarum: Antibacterial, Antioxidant, and Cytotoxic Properties Under In Vitro and Food Circumstances.Probiotics and antimicrobial proteins · 2026Article
- INM004: Polyclonal Neutralizing Antibodies Against Shiga Toxin as a Treatment for Hemolytic Uremic Syndrome.Toxins · 2025Review
- Cryo-EM structures of engineered Shiga toxin-based immunogens capable of eliciting neutralizing antibodies with therapeutic potential against hemolytic uremic syndrome.Protein science : a publication of the Protein Society · 2025Article
- A better future for children with STEC-hemolytic uremic syndrome: news from Argentina.Pediatric nephrology (Berlin, Germany) · 2025Article
Corrections and comments
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Authors and funding
29 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundShiga toxin-producing Escherichia coli-associated hemolytic uremic syndrome (STEC-HUS) is a severe condition mainly affecting children. It is one of the leading causes of acute kidney injury in the pediatric population. There is no established therapy for this disease. INM004 is an anti-Shiga toxin composed of equine polyclonal antibodies. This study is aimed at assessing the safety, pharmacokinetics, and efficacy of INM004 in pediatric patients with STEC-HUS.
methodsPhase 2, open-label clinical trial with an historical control arm. Patients in the treatment arm received two doses of INM004. The primary endpoints were the safety profile, pharmacokinetics, and efficacy (dialysis days) of INM004. Secondary endpoints included other kidney and extrarenal outcomes. Propensity score matching was used for efficacy comparisons between arms.
resultsFifty-seven and 125 patients were enrolled in the treatment and control arm, respectively. After propensity score matching, 52 patients remained in each arm. INM004 was well-tolerated. Eight adverse events were considered possibly related, none of which were serious or severe. In the primary efficacy endpoint, patients of the treatment arm presented a non-statistically significant difference of two dialysis days. On secondary endpoints, non-statistically significant trends toward fewer patients needing dialysis and dialysis for more than 10 days, and shorter time to glomerular filtration rate normalization, were observed favoring the treatment arm.
conclusionsINM004 showed an adequate safety profile. Efficacy non-statistically significant trends suggesting a beneficial effect in the amelioration of kidney injury were observed. These results encourage the conduction of a phase 3 study of INM004 in pediatric patients with STEC-HUS.
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