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A 24-week, Phase III, Open-label, Non-comparative, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

Trial Profile

A 24-week, Phase III, Open-label, Non-comparative, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Daprodustat (Primary) ; Iron
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • 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 NCT02969655).
    • 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 (NCT02969655 and NCT03029208).
    • 01 Dec 2017 Status changed from recruiting to completed.
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