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

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Oct 2017

At a glance

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

    • 18 Oct 2017 the China Food and Drug Administration (CFDA) has accepted the company's recently submitted New Drug Application for registration of roxadustat for the treatment of anemia in dialysis-dependent CKD (DD-CKD) and non-dialysis-dependent CKD (NDD-CKD) patients. Data from this and another phase III trial (profile 257941) supported the application.
    • 23 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 09 May 2017 According to a FibroGen media release, NDA submission in China is targeted in the third quarter of 2017.
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