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A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2022

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At a glance

  • Drugs Roxadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ALPS
  • Sponsors Astellas Pharma BV

    • Most Recent Events

    • 18 May 2022 Results from four pivotal trials (ASCEND-NHQ , ALPS, ANDES, OLYMPUS) assessing indirect treatment comparison (ITC) of changes in SF-36 Vitality score observed in placebo-controlled RCTs of daprodustat and roxadustat presented at the 27th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research
    • 14 Dec 2021 Results of pooled post-hoc analysis assessing the effects of roxadustat in patients (pts) with NDD-CKD across all available BL Hb values from three Phase 3 NDD-CKD trials (OLYMPUS, ALPS, ANDES) presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 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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