A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA).

Trial Profile

A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA).

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2018

At a glance

  • Drugs Ferumoxytol (Primary) ; Ferric carboxymaltose
  • Indications Iron deficiency anaemia
  • Focus Adverse reactions; Registrational
  • Acronyms FIRM
  • 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.
    • 12 Dec 2017 Results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 14 Nov 2017 Status changed from active, no longer recruiting to completed.
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