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A pivotal study of Ilofotase-alfa

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Trial Profile

A pivotal study of Ilofotase-alfa

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Ilofotase alfa (Primary)
  • Indications Acute kidney injury
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 13 Nov 2025 New trial record
  • 02 Oct 2025 According to an AM-Pharma media release, the primary endpoint from NCT06168799 trial is serum creatinine ratio (sCrR), a sensitive measure of kidney function changes that closely correlates with Major Adverse Kidney Events at 60 days (MAKE60). MAKE60 is an FDA-registrable endpoint, which would serve as the primary endpoint in the expected pivotal Phase 3 trial for ilofotase alfa.

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