A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Recruiting now · Phase 3

Conditions studied: Iron Deficiency Anemia

In brief

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).

Key facts

Study ID

NCT03893045

Run by

AMAG Pharmaceuticals, Inc.

People needed

75

Starts

2019-09-18

Expected to finish

2026-10-01

Last updated by the study team

2026-04-17

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 2 years to <18 years of age at time of consent
• Has IDA defined as:
• Hemoglobin (Hgb) <11.0 g/dL AND
• Any one or more of the following:
• Transferrin saturation (TSAT) <20%
• ferritin <100 ng/mL
• Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate

You may not qualify if…

• Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
• History of allergy to intravenous (IV) iron
• History of ≥2 clinically significant drug allergies
• Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
• Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
• Hgb ≤7.0 g/dL
• Serum ferritin level >600 ng/mL

Where it is running

• Biomedical Research LLC — Miami, Florida, United States (enrolling)
• Optimus U Corporation — Miami, Florida, United States (enrolling)
• Sun Research Institute — San Antonio, Texas, United States (enrolling)
• 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
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw, Poland
• University of Florida — Gainesville, Florida, United States
• Gwinnett Research Institute — Buford, Georgia, United States

Full record on ClinicalTrials.gov

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