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

A Multi-center, Open-label, Randomized, Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin.

This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.

A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.

Inclusion Criteria:

• Male of female, 18 years old or older.
• Have been receiving chronic hemodialysis therapy
• On stable EPO dosing regimen.
• Have signed patient informed consent.
• Predetermined serum ferritin and TSAT levels.
• Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.
• Pregnant or lactating.
• A known sensitivity to Ferrlecit

Exclusion Criteria:

• Scheduled for renal transplant.
• A serious concomitant medical disorders incompatible with participation in the study.
• Unable to cooperate or comply with the protocol.
• Use of any investigation agent within 30 days prior to study or during the course of the study.
• Judged by the investigator as unsuitable for enrollment for any reason.