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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

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