Last updated on November 2017

A Phase III, Randomised, Open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofer®) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral iron therapy.


Brief description of study

A Phase III, Randomised, Open-label, comparative safety and efficacy trial of intravenous iron isomaltoside (Monofer®) and iron sucrose in subjects with iron deficiency anemia who are intolerant or unresponsive to oral iron therapy.

Detailed Study Description

The trial is a randomised, comparative, open-label trial. Subjects with iron deficiency anemia (IDA) who are intolerant or unresponsive to oral iron therapy or in whom the screening haemoglobin (Hb) measurement in Investigators' opinion were sufficiently low as to require rapid repletion of iron stores to minimize the risk of receiving a blood transfusion will be randomised 2:1 to 1 of the following treatment groups:

  • Group A: iron isomaltoside 1000 (Monofer®)
  • Group B: iron sucrose (Venofer®)

    Clinical Study Identifier: TX9472

    .

    Contact Investigators or Research Sites near you

    Start Over

    Please choose location

    View all locations

    Carlos M. Manzano

    AppleMed Research Group, LLC
    Miami, FL USA
      Connect »