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RECRUITING
NCT03893045
PHASE3

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

Sponsor: AMAG Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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