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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 May 2017

At a glance

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

    • 09 May 2017 According to a FibroGen media release, NDA submission in China is targeted in the third quarter of 2017.
    • 14 Feb 2017 Planned End Date changed from 1 Apr 2017 to 1 Jun 2017.
    • 30 Jan 2017 According to a FibroGen media release, the 52-week safety assessment in at least 100 patients is ongoing with expected study completion in June 2017 with full results from the study are expected to be reported in due course.
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