Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients

Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

Inclusion Criteria:

• Male or female pediatric end-stage renal disease (ESRD) patients.
• Predetermined TSAT and serum ferritin levels
• Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
• Receiving a stable epoetin (EPO) dosing regimen.

Exclusion Criteria:

• Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
• Blood transfusion.
• Hypersensitivity to Ferrlecit®.
• Significant inflammatory conditions.