Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin

A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Inclusion Criteria:

• Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
• Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
• Predetermined TSAT and serum Ferritin (at the screening visit).
• Receiving a stable EPO dosing regimen.

Exclusion Criteria:

• Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
• Hypersensitivity to Ferrlecit or any of its inactive components.
• High TSAT level.
• High Serum Ferritin