
This phase 3 clinical trial protocol for ilofotase alfa, a recombinant human alkaline phosphatase compound, aims to confirm the survival benefit observed in a phase 2 trial, which showed improved renal function and reduced mortality in patients with sepsis-associated acute kidney injury (AKI) requiring vasopressors. The trial will be conducted at multiple sites globally, with up to 1400 patients enrolled. Interim analyses will be conducted, and the trial may be stopped early based on predefined decision rules. The trial will also include separate cohorts for patients with COVID-19 and moderate to severe chronic kidney disease.
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