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Ferumoxytol vs Oral Iron in Pediatric ND-CKD
NCT01155388Phase 3
Key facts
- Status
- Terminated
- Start
- Oct 2011
- Primary completion
- Jun 2014
- Countries
- 1
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Modality
- Nanoparticles, Small Molecules
- Drugs
- ferumoxytol
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 3, randomised, open-label trial of ferumoxytol in iron deficiency anemia (IDA) (2 arms), sponsored by AMAG Pharmaceuticals, Inc. Primary endpoint: Mean Change In Hemoglobin From Baseline To Week 5. Started Oct 2011; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Ferumoxytol
IV Ferumoxytol
Oral Iron
Oral Iron (Ferrous fumarate)
03
Who it enrols
Pediatric patients (6 months to <18 years) with nondialysis-dependent CKD and iron deficiency anemia (Hb <11.0 g/dL, TSAT <20%). Excludes patients with Hb <= 7.0 g/dL or ferritin > 600 ng/mL.
04
Endpoints
Primary
Mean Change In Hemoglobin From Baseline To Week 5
Secondary
Area Under The Curve Of Ferumoxytol
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