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Phase 3 Double-Blind Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Switch / Maintenance Study>

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Trial Profile

Phase 3 Double-Blind Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Switch / Maintenance Study>

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Enarodustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Switch / Maintenance Study
  • Sponsors Japan Tobacco

    • Most Recent Events

    • 28 Sep 2020 According to a JW Pharmaceutical media release, JW Pharmaceutical announced on the 28th Sep 2020 that Japan Tobacco Inc. (JT) acquired approval on new drug application (NDA) for 2mg and 4mg tablet products of JTZ-951, therapeutic agent for renal anemia, from the Ministry of Health, Labour and Welfare (MHLW) in Japan.Approval for manufacturing and marketing acquired in Japan based on successful phase 3 clinical trials of JTZ-951.
    • 29 Nov 2019 According to a Japan Tobacco media release, Japan Tobacco filed a New Drug Application for JTZ-951, for anemia associated with chronic kidney disease (CKD).
    • 12 Jul 2019 Marketing application for JTZ-951 in Japan will be submitted based on the results of this and other clinical studies.
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