07Apr 2023
Hope for Sepsis Patients: The Promising Results of a Double-Blind, Placebo-Controlled Trial of Recombinant Human Alkaline Phosphatase

Hope for Sepsis Patients: The Promising Results of a Double-Blind, Placebo-Controlled Trial of Recombinant Human Alkaline Phosphatase

The study describes a phase 3 randomized controlled trial to confirm the safety and effectiveness of ilofotase alfa, a recombinant human alkaline phosphatase compound, in reducing mortality in critically ill patients with sepsis-associated acute kidney injury (AKI) requiring vasopressors. The trial will enroll up to 1400 patients across ∼120 sites globally and will analyze patients with COVID-19 disease and "moderate to severe" chronic kidney disease as two separate cohorts of 100 patients each. The trial will have up to four interim analyses, and the results will be published in a peer-reviewed scientific journal. The study reports that ilofotase alfa showed no safety or tolerability concerns in a phase 2 trial and significantly improved renal function, and reduced all-cause mortality by >40% in the ilofotase alfa group.

  • #family health

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