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A Phase 3, Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoiesis Stimulating Agent Treatment

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Trial Profile

A Phase 3, Long Term Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia Converted From Erythropoiesis Stimulating Agent Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Roxadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 20 Sep 2019 According to a FibroGen media release, Japan's Ministry of Health, Labour and Welfare (MHLW) approved roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients.
    • 08 Aug 2019 According to a FibroGen media release, the regulatory decision for roxadustat approval in Japan is expected in the second half of 2019.
    • 22 Feb 2019 According to a FibroGen media release, NDA is under review by the Pharmaceuticals and Medical Devices Agency (PMDA).
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