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).