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An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study

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Trial Profile

An Open-Label Study of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Who Previously Experienced Abnormal Liver Chemistry Test Results While Receiving Tolvaptan: The ALERT Study

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2023

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At a glance

  • Drugs Lixivaptan (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Adverse reactions; Registrational
  • Acronyms ALERT
  • Sponsors Palladio Biosciences

Most Recent Events

  • 07 Jun 2022 Planned End Date changed from 1 Jan 2024 to 1 Oct 2022.
  • 07 Jun 2022 Planned primary completion date changed from 1 Oct 2023 to 1 Sep 2022.
  • 02 Jun 2022 According to a Centessa Pharmaceuticals media release, the company has decided to discontinue development of lixivaptan for ADPKD including both the ACTION and the open-label ALERT Study based on a thorough reassessment of the commercial potential of lixivaptan as a potential best-in-class therapy for patients with ADPKD, and the incremental development challenges and associated costs, following a recent observation of ALT and AST elevations in one subject in the ALERT Study.

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