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A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users

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Trial Profile

A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Aug 2023

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At a glance

  • Drugs Daprodustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 29 Jun 2020 According to a GlaxoSmithKline media release, the company received approval of a Japanese New Drug Application (JNDA) by the Ministry of Health, Labour and Welfare for daprodustat for the treatment of patients anaemia due to chronic kidney disease (CKD), based on the data from this and other two studies (NCT02829320 and NCT03029208).
    • 21 Aug 2019 According to a GlaxoSmithKline media release, the company has submitted a Japanese New Drug Application (JNDA) to the Ministry of Health, Labour and Welfare seeking marketing approval for daprodustat for the treatment of patients with renal anaemia due to chronic kidney disease (CKD), based on the data from this and other two studies (NCT03029208 and NCT02829320).
    • 29 Oct 2018 Primary endpoint has been met. (Mean hemoglobin (Hgb) during the primary efficacy evaluation period), according to a GlaxoSmithKline media release.
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