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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

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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: 10 Apr 2023

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At a glance

  • Drugs Vadadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Mitsubishi Tanabe Pharma America

Most Recent Events

  • 29 Jun 2020 According to Akebia Therapeutics Media Release, company has obtained manufacturing and marketing approval of vadadustat as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients by the Ministry of Health, Labour and Welfare in Japan on June 29, 2020.
  • 05 May 2020 According to an Akebia Therapeutics media release, in collaboration with Mitsubishi Tanabe, the company is advancing key pre-commercial activities in support of the first regulatory approval of vadadustat expected in Japan this year.
  • 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.

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