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

PHASE3RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

September 18, 2019

Primary Completion Date

July 31, 2025

Study Completion Date

October 31, 2025

Conditions
Iron Deficiency Anemia
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).

Trial Locations (15)

30519

NOT_YET_RECRUITING

Gwinnett Research Institute, Buford

32608

NOT_YET_RECRUITING

University of Florida, Gainesville

33125

RECRUITING

Optimus U Corporation, Miami

33184

RECRUITING

Biomedical Research LLC, Miami

72202

NOT_YET_RECRUITING

Arkansas Children's Hospital, Little Rock

78215

RECRUITING

Sun Research Institute, San Antonio

Unknown

NOT_YET_RECRUITING

JSC Saules seimos medicinos centras, Kaunas

NOT_YET_RECRUITING

Klaipeda Children's Hospital, Klaipėda

NOT_YET_RECRUITING

Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos, Vilnius

NOT_YET_RECRUITING

Osrodek Badan Klinicznych In Vivo sp. z o.o., Bydgoszcz

NOT_YET_RECRUITING

Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek, Dębica

NOT_YET_RECRUITING

Pro Familia Altera Sp. z o.o., Katowice

NOT_YET_RECRUITING

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

NOT_YET_RECRUITING

Centrum Zdrowia MDM, Warsaw

NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw

Sponsors
All Listed Sponsors
lead

AMAG Pharmaceuticals, Inc.

INDUSTRY