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A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis

Trial Profile

A Phase 3, Randomized, Open-Label, Active-Controlled Study of Efficacy and Safety of FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease on Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Aug 2019

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At a glance

  • Drugs Roxadustat (Primary) ; Epoetin alfa
  • Indications Anaemia
  • Focus Therapeutic Use
  • Sponsors FibroGen
  • Most Recent Events

    • 08 Aug 2019 According to a FibroGen media release, the regulatory decision for Roxadustat in China is expected in the third quarter of 2019.
    • 24 Jul 2019 Results assessing the efficacy and safety of roxadustat for the treatment of anemia in patients undergoing dialysis in China published in the New England Journal of Medicine
    • 18 Dec 2018 According to an AstraZeneca media release, roxadustat has been approved in China by the National Medical Products Administration (NMPA) for the treatment of patients with anaemia caused by chronic kidney disease (CKD) that are on dialysis (haemodialysis or peritoneal dialysis).
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