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)
Start Date
8/13/2018
Completion Date
8/31/2026
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.
Detailed Description
This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 \[max 510 mg/dose\]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose. Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period. Subjects receive the following: • Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later OR • Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Ferumoxytol
Iron sucrose
Conditions
Locations
Memorial Healthcare System
Hollywood, Florida 33021
United States
Wayne State University
Detroit, Michigan 48201
United States
Children's Mercy Hospital
Kansas City, Missouri 64108
United States
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York 11042
United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York 10029
United States
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York 10467
United States
Akron Nephrology Associates, Inc.
Akron, Ohio 44302
United States
West Virginia University
Morgantown, West Virginia 26506
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