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A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients

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Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients

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 Registrational; Therapeutic Use
  • Acronyms HIMALAYAS
  • 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
    • 09 Nov 2022 Results of systematic review included some of the data from DOLOMITES, HIMALAYAS and ROCKIES for assessing efficacy and safety of hypoxia-inducible factor prolyl hydroxylase inhibitors for treatment of anaemia of chronic kidney disease, presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 09 Nov 2021 According to a FibroGen media release, the company announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of CKD.

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