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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).

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).

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

Latest Information Update: 12 Jul 2019

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At a glance

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

    • 12 Jul 2019 Marketing application for JTZ-951 in Japan will be submitted based on the results of this and other clinical studies.
    • 12 Jul 2019 According to a Japan Tobacco media release, Primary endpoint (Differences in mean hemoglobin at week 20, 22 and 24 ( non-inferiority criterion)) has been met.
    • 12 Jul 2019 Results presented in a Japan Tobacco, Media Release.
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