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A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Sponsor: AMAG Pharmaceuticals, Inc.
Summary
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2019-09-18
Completion Date
2025-10
Last Updated
2024-08-12
Healthy Volunteers
No
Conditions
Interventions
ferumoxytol
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
Iron sucrose
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
Locations (15)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
University of Florida
Gainesville, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Biomedical Research LLC
Miami, Florida, United States
Gwinnett Research Institute
Buford, Georgia, United States
Sun Research Institute
San Antonio, Texas, United States
JSC Saules seimos medicinos centras
Kaunas, Lithuania
Klaipeda Children's Hospital
Klaipėda, Lithuania
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Osrodek Badan Klinicznych In Vivo sp. z o.o.
Bydgoszcz, Poland
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
Dębica, Poland
Pro Familia Altera Sp. z o.o.
Katowice, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Poland
Centrum Zdrowia MDM
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland