Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

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

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• Hemoglobin < or = 11.5 gm/dL

• Stable dose or not receiving EPO

• Renal Anemia

Exclusion Criteria:

• IV iron with last 6 months

• Chronic infection, malignancy,major surgery within last month

• Blood Transfusion with last two months

• Significant blood loss within last 3 months

• Concomitant sever diseases of the liver