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A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

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Trial Profile

A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Epoetin zeta (Primary) ; Epoetin alfa
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AiME - 01
  • Sponsors Hospira; Pfizer

Most Recent Events

  • 07 Aug 2018 The protocol was amended to require that patients be on stable IV epoetin alfa treatment for ≥4 weeks before randomization, the target level of hemoglobin was changed from 10.0-12.0 to 9.0-11.0 g/dl and the upper eligibility age range from 75 to 80 years, as per the results published in the Clinical Journal of The American Society of Nephrology: CJASN.
  • 15 Apr 2014 New trial record

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