Last updated on November 2017

A Phase III, Randomized, Open-Label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer (R)) and Iron Sucrose in Subjects with Iron Deficiency Anemia who are Intolerant or Unresponsive to Oral Iron Therapy or in whom the Hemoglobin Measurement in Investigators' Opinion were Sufficiently Low as to Require Rapid Repletion of Iron Stores to Minimize the Risk of Receiving a Blood Transfusion.


Brief description of study

A Phase III, Randomized, Open-Label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside (Monofer (R)) and Iron Sucrose in Subjects with Iron Deficiency Anemia who are Intolerant or Unresponsive to Oral Iron Therapy or in whom the Hemoglobin Measurement in Investigators' Opinion were Sufficiently Low as to Require Rapid Repletion of Iron Stores to Minimize the Risk of Receiving a Blood Transfusion.

Detailed Study Description

The primary objectives of the trial is to evaluate the safety and efficacy of IV iron isomaltoside when compared to iron sucrose in its ability to increase hemoglobin in subjects with IDA, when oral iron preparations are ineffective.

Clinical Study Identifier: TX82034

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Crystal Beaber, MA, CCRC

Gastroenterology Associates of Tidewater
Chesapeake, VA USA
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