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Ferric Carboxymaltose vs Iron Dextran in Women with Iron Deficiency Anemia from Heavy Uterine Bleeding
NCT01307007Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2010
- Primary completion
- May 2011
- Sponsor
- American Regent, Inc.
- Modality
- Small Molecules
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 2, randomised, open-label trial of ferric carboxymaltose in iron deficiency anemia (IDA) (2 arms), sponsored by American Regent, Inc. Primary endpoints: Changes in Blood Markers at Day 35 and Adverse Events at Day 35. Started Sep 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Ferric Carboxymaltose
15 mg/kg up to 1000 mg IV on Day 0
Iron Dextran
Test dose 25 mg, then remainder up to 1000 mg IV on Day 0
03
Who it enrols
Adult women with iron deficiency anemia secondary to heavy uterine bleeding, excluding those with chronic kidney disease, hypophosphatemia, or recent IV iron treatment.
04
Endpoints
Primary
Changes in Blood Markers
Adverse Events
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