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A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

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Trial Profile

A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2021

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At a glance

  • Drugs Ferumoxytol (Primary) ; Iron sucrose
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors AMAG Pharmaceuticals

Most Recent Events

  • 05 Feb 2018 According to an AMAG Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved sNDA application to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease (CKD) indication to include all eligible adult Iron Deficiency Anemia (IDA) patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Data from this and two other phase 3 trials supported the submission.
  • 02 Dec 2013 New trial record
  • 10 Dec 2012 Primary endpoint 'Response-rate' has been met.

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