A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

PHASE3RecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

August 13, 2018

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Chronic Kidney Disease; 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 (21)

10029

ACTIVE_NOT_RECRUITING

Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH), New York

10467

RECRUITING

Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM), The Bronx

11042

NOT_YET_RECRUITING

The Feinstein Institute Medical Research Organization of Northwell Health, Inc., Lake Success

26506

RECRUITING

West Virginia University, Morgantown

33021

NOT_YET_RECRUITING

Memorial Healthcare System, Hollywood

44302

RECRUITING

Akron Nephrology Associates, Inc., Akron

48201

ACTIVE_NOT_RECRUITING

Wayne State University, Detroit

64108

RECRUITING

Children's Mercy Hospital, Kansas City

Unknown

RECRUITING

Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika, Budapest

RECRUITING

University Of Szeged, Szeged

NOT_YET_RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

ACTIVE_NOT_RECRUITING

Klaipeda Children's Hospital, Klaipėda

NOT_YET_RECRUITING

Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital), Vilnius

RECRUITING

Instituto Mexicano De Trasplantes S.C, Cuernavaca

ACTIVE_NOT_RECRUITING

JM Research, SC, Cuernavaca

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

RECRUITING

Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics), Mexico City

NOT_YET_RECRUITING

Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku, Bialystok

ACTIVE_NOT_RECRUITING

Specjalistyczne Gabinety Sp. z o.o, Krakow

NOT_YET_RECRUITING

University Children Hospital, Krakow

NOT_YET_RECRUITING

Polish Mother's Memorial Hospital Research Institute, Lodz

Sponsors
All Listed Sponsors
lead

AMAG Pharmaceuticals, Inc.

INDUSTRY