Efficacy of INM004 in Children With STEC-HUS

Exclusion Criteria

• •1. Start of dialysis within 48 hours prior to admission to the participating institution.
• •2. More than 24 hours from diagnosis of STEC-HUS at the participating institution up to randomization.
• •3. History of chronic/recurrent hemolytic anemia, thrombocytopenia, or CKD.
• •4. Personal and/or family history of atypical HUS.
• •5. Suspected HUS secondary to infectious processes other than gastrointestinal (e.g., Streptococcus pneumoniae, HIV).
• •6. Suspected HUS secondary to other etiologies (e.g., drug-associated HUS, neoplasms, bone marrow or solid organ transplantation, autoimmune disorders).
• •7. Any other acute or chronic medical condition that, in the opinion of the investigator, may interfere with the evaluation of the efficacy and/or safety of the study medication.
• •8. History of: a) anaphylaxis of any kind; b) prior administration of equine serum (e.g., antivenom, anti-arachnid serum, anti-SARS-CoV-2 serum, etc.) or an allergic reaction from contact or exposure to horses.
• •9. Pregnant or breastfeeding woman.
• •10. Impossibility of hospitalization in the participating institution.
• •11. Concurrent participation in another clinical trial or having participated in a clinical trial in the last 3 months.
• •12. Severe malnutrition. Defined when the weight is three standard deviations below the median, according to height, age and sex as per WHO guidelines.
• •13. Medical conditions that may affect kidney function or cause/enhance neurological symptoms or signs:
• •* Congenital or acquired anomalies that may affect functioning renal mass.
• •* Epilepsy or structural abnormalities of the brain that may increase the risk of seizures.
• •* Trisomy 21.
• •* Prematurity (born before 28 weeks gestation).
• •* Other (according to investigator criteria).