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A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients

Trial Profile

A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 May 2020

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At a glance

  • Drugs Roxadustat (Primary) ; Epoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ROCKIES
  • Sponsors AstraZeneca
  • Most Recent Events

    • 20 May 2020 According to an Astellas Pharma media release, results from these studies support roxadustat as efficacious in increasing and maintaining target hemoglobin levels with reduced use of intravenous iron in adult patients with CKD anemia, both those who are dialysis dependent (DD) and those non-dialysis dependent (NDD). These data also support a favorable risk:benefit profile with cardiovascular (CV) and general safety of roxadustat.
    • 20 May 2020 According to an Astellas Pharma media release, the MAA is supported by positive results from a pivotal Phase 3 program (PYRENEES, ALPS, ANDES, HIMALAYAS, SIERRAS, OLYMPUS, ROCKIES, DOLOMITES). The MAA dossier includes the DOOMITES study, the results of which will be disclosed later this year. The company looks forward to the review and assessment by EMA in the hope of bringing this innovative treatment to patients across the EU.
    • 20 May 2020 According to an Astellas Pharma media release, the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has been accepted by the European Medicines Agency (EMA) for regulatory review.
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