Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Inclusion Criteria:

• Age > or = 12 to < or = 16 years
• Parent and/or legal guardian able to give informed consent
• Subject able to give written assent for participating in the study
• NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
• Hemoglobin indicative of anemia
• Ferritin indicative of iron deficiency anemia
• If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion Criteria:

• Known history of hypersensitivity to any component of Venofer
• Parenteral iron within 14 days of the screening visit
• Dialysis dependent-CKD
• Chronic or serious active infection
• Pregnancy or lactation
• Subjects with causes of iron deficiency anemia other than CKD
• Blood transfusion within the last month or anticipated during the study
• Body weight < 55 pounds
• Received an investigational drug within 30 days before screening