VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Inclusion Criteria:

• Males or females > or = 12 years of age
• NDD-CKD subjects
• Baseline hemoglobin < or = 11g/dl
• Stable erythropoietin (EPO) status

Exclusion Criteria:

• Known hypersensitivity to ferrous sulfate or IV iron
• Unstable EPO status
• Anemia not related to CKD
• Chronic, serious infection
• Recent IV iron
• Recent blood transfusion
• Recent blood loss
• Need for surgery
• Received investigational drug within 30 days
• Female subjects who are pregnant or lactating