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

A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.

This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Inclusion Criteria:

• Male or female patients ≥ 18 years.
• Have chronic kidney disease per K/DOQI guidelines.
• No change in EPO status during study.
• Baseline hemoglobin of ≤ 11.0 g/dl.

Exclusion Criteria:

• Women who are pregnant or lactating.
• Received another investigational drug or device within 30 days.
• Recent parenteral or oral iron therapy.
• Patients with active GI bleeding or acute bleeding within 4 weeks.
• Patients that have other causes of anemia.
• Major surgery within 30 days or anticipated or planned major surgery during the study.
• Patients whose EPO status changes while on study.
• Patients with active infections.
• Recent blood transfusions.
• Patients with any known allergies to iron products.