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RECRUITING
NCT03619850
PHASE3

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.

View on ClinicalTrials.gov

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

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 (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