drugset / Trial / NCT01950247

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron

NCT01950247

Phase 4 Completed 1025 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Timeline

Start
2013-08-15
Primary completion
2015-05-20
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg