Pharmacokinetic of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

Open-label Multicenter, Pharmacokinetic Study of a Single Dose of Intravenous Iron Sucrose in Adolescents on Hemodialysis or Peritoneal Dialysis Receiving Epoetin

This is an open-label, multicenter pharmacokinetic study of Hemodialysis (HD) or Peritoneal Dialysis (PD) patients receiving erythropoietin. Patients were administered 100mg of iron sucrose undiluted by slow IV push over 5 minutes. Patients underwent serial blood draws and were subsequently followed for 7 days for safety endpoints.

This is an open-label, multicenter pharmacokinetic study of HD of adolescent PD patients receiving erythropoietin. Patients between the ages of 12 and 18 were administered 100mg of iron sucrose, undiluted by slow IV push over 5 minutes, and underwent serial blood draws. The patients were subsequently followed for 7 days for safety endpoints.

Inclusion Criteria:

• Age between 12 and 18 years
• History of Chronic Renal Failure requiring HD or PD
• Hgb </= 13 g/dL
• Ferritin < 800 ng/ml
• Transferrin Saturation (TSAT) < 50%
• Receiving epoetin

Exclusion Criteria:

• Known Sensitivity to Iron Sucrose
• Severe Concomitant disease of the liver or cardiovascular system
• Serious bacterial Infection
• Pregnancy / Lactation
• Active Hepatitis
• Patients with Causes of iron deficiency other that Chronic Renal Failure
• Blood Transfusion
• Body Weight < 25 kilograms
• Currently being treated for Asthma
• Received investigational drug within last 30 days