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A Phase III, Open-label Study of MT-6548 in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Trial Profile

A Phase III, Open-label Study of MT-6548 in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jul 2019

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At a glance

  • Drugs Vadadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Mitsubishi Tanabe Pharma Corporation
  • Most Recent Events

    • 23 Jul 2019 According to Akebia Therapeutics Media Release, the company announced that Mitsubishi Tanabe Pharma Corporation has submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labor and Welfare in Japan for manufacturing and marketing approval of vadadustat as a treatment for anemia due to chronic kidney disease (CKD) based on two pivotal studies and two additional Phase 3 single-arm studies.
    • 18 Mar 2019 According to Mitsubishi Tanabe Pharma Corporation Media Release, based on data from these two pivotal studies as well as from two additional single-arm studies in peritoneal dialysis and hemodialysis subjects the company expects to submit a Japanese New Drug Application in 2019.
    • 12 Mar 2019 According to an Akebia Therapeutics Media Release, the company will discuss these findings on investor update call. Additional data from the studies are expected be presented by Mitsubishi Tanabe Pharma Corporation at an upcoming medical meeting.
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