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Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study> (SYMPHONY ND)

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Trial Profile

Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study> (SYMPHONY ND)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2022

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At a glance

  • Drugs Enarodustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SYMPHONY ND
  • Sponsors Japan Tobacco

Most Recent Events

  • 02 Dec 2021 Status changed from active, no longer recruiting to completed.
  • 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).

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