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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)
Sponsor: AMAG Pharmaceuticals, Inc.
Summary
Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
Official title: A Phase 3, Randomized, Open-Label, Multicenter 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)
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2018-08-13
Completion Date
2024-08-31
Last Updated
2024-08-12
Healthy Volunteers
No
Interventions
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).
Locations (21)
Memorial Healthcare System
Hollywood, Florida, United States
Wayne State University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, United States
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States
Akron Nephrology Associates, Inc.
Akron, Ohio, United States
West Virginia University
Morgantown, West Virginia, United States
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary
University Of Szeged
Szeged, Hungary
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Klaipeda Children's Hospital
Klaipėda, Lithuania
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
Vilnius, Lithuania
Instituto Mexicano De Trasplantes S.C
Cuernavaca, Mexico
JM Research, SC
Cuernavaca, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, Mexico
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
Bialystok, Poland
Specjalistyczne Gabinety Sp. z o.o
Krakow, Poland
University Children Hospital
Krakow, Poland
Polish Mother's Memorial Hospital Research Institute
Lodz, Poland