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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
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.
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).
Memorial Healthcare System
Hollywood, Florida, United States
NOT_YET_RECRUITINGWayne State University
Detroit, Michigan, United States
ACTIVE_NOT_RECRUITINGChildren's Mercy Hospital
Kansas City, Missouri, United States
RECRUITINGThe Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York, United States
NOT_YET_RECRUITINGIcahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, United States
ACTIVE_NOT_RECRUITINGMontefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States
RECRUITINGAkron Nephrology Associates, Inc.
Akron, Ohio, United States
RECRUITINGWest Virginia University
Morgantown, West Virginia, United States
RECRUITINGSemmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary
RECRUITINGUniversity Of Szeged
Szeged, Hungary
RECRUITING...and 11 more locations
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5
Time frame: 35 days
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Time frame: 49 days
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Time frame: 49 days
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