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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)
129 patients around the world
Available in Mexico
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).
AMAG Pharmaceuticals, Inc.
2Research sites
129Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- Male or female 2 years to <18 years of age at time of consent.Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL.Has Chronic Kidney Disease defined as one of the following:on chronic hemodialysis;receiving chronic peritoneal dialysis;estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate.All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study.
- Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose.History of allergy to intravenous (IV) iron.History of multiple drug allergies (>2).Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg).Hemoglobin ≤7.0 g/dL.Serum ferritin level >600 ng/mL.
Sites
Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
Instituto Nacional de Pediatría - México
Recruiting
SponsorAMAG Pharmaceuticals, Inc.
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03619850
