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A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis

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Trial Profile

A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2023

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At a glance

  • Drugs Roxadustat (Primary) ; Epoetin alfa
  • Indications Anaemia
  • Focus Therapeutic Use
  • Acronyms SIERRAS
  • Sponsors FibroGen

    • Most Recent Events

    • 07 Feb 2023 Results of pooled analysis from four studies (n=2142:NCT02021318, NCT02052310, NCT02273726, NCT02174731) assessing the safety of roxadustat in patients with non dialysis dependent or incident dialysis dialysis dependent chronic kidney disease published in the Advances in Therapy
    • 14 Sep 2021 Results of pooled analysis assessing efficacy and safety of roxadustat in the largest possible global population of DD patients with anemia of CKD from four phase 3 trials (PYRENEES, HIMALAYAS, SIERRAS and ROCKIES) published in the Advances in Therapy
    • 19 Aug 2021 According to an Astellas Pharma, FibroGen media release, the European Commission (EC) has approved EVRENZO™ (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

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