A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Trial Profile

A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2017

At a glance

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

    • 21 Sep 2017 Status changed from not yet recruiting to recruiting.
    • 09 May 2017 According to a FibroGen media release, the company received approval from FDA to conduct this trial. This trial is expected to initiate in the third quarter of 2017.
    • 31 Mar 2017 According to a FibroGen media release, the company anticipates initiating this trial in the first half of 2017.
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