drugset / Trial / NCT02086968

Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

NCT02086968

Phase 4 Completed 198 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

Timeline

Start
2014-01-01
Primary completion
2016-07-16
Completion
2017-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral