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A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

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Trial Profile

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Roxadustat (Primary) ; Darbepoetin alfa; Darbepoetin alfa; Epoetin alfa; Epoetin alfa
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms Pyrenees
  • Sponsors Astellas Pharma BV

    • Most Recent Events

    • 19 Sep 2021 Results assessing the efficacy and safety of roxadustat in patients with end-stage kidney disease on dialysis for at least 4 months assessing 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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