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

NCT03893045 · tracked via the Priya Life Science USA tracker

Sponsor

AMAG Pharmaceuticals, Inc.

Phase

Phase 3

Started

2019-09-18

Last updated

2026-04-17

Condition(s) studied

Iron Deficiency Anemia

Investigational drug(s) / intervention(s)

ferumoxytolIron sucrose

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).

Study 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).

Eligibility

Sex

ALL

Min age

2 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: 1. Hemoglobin (Hgb) \<11.0 g/dL AND 2. Any one or more of the following: * Transferrin saturation (TSAT) \<20% * ferritin \<100 ng/mL 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of ≥2 clinically significant drug allergies 4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening) 5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg) 6. Hgb ≤7.0 g/dL 7. Serum ferritin level \>600 ng/mL

Primary outcome measure(s)

Change in Hemoglobin from Baseline to Week 5 — 35 days
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5

Trial sites (15)

Facility	City	Region	Status
Arkansas Children's Hospital	Little Rock	Arkansas	Not Yet Recruiting
University of Florida	Gainesville	Florida	Not Yet Recruiting
Optimus U Corporation	Miami	Florida	Recruiting
Biomedical Research LLC	Miami	Florida	Recruiting
Gwinnett Research Institute	Buford	Georgia	Not Yet Recruiting
Sun Research Institute	San Antonio	Texas	Recruiting
JSC Saules seimos medicinos centras	Kaunas	Lithuania	Not Yet Recruiting
Klaipeda Children's Hospital	Klaipėda	Lithuania	Not Yet Recruiting
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos	Vilnius	Lithuania	Not Yet Recruiting
Osrodek Badan Klinicznych In Vivo sp. z o.o.	Bydgoszcz	Poland	Not Yet Recruiting
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek	Dębica	Poland	Not Yet Recruiting
Pro Familia Altera Sp. z o.o.	Katowice	Poland	Not Yet Recruiting
Korczowski Bartosz, Gabinet Lekarski	Rzeszów	Poland	Not Yet Recruiting
Centrum Zdrowia MDM	Warsaw	Poland	Not Yet Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Poland	Not Yet Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03893045 on ClinicalTrials.gov ↗ ← All trials in the USA