Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
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The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.
Condition or disease
Drug: ferumoxytol or oral iron
This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients ≥18 years.
Stable supplemental EPO therapy.
Baseline hemoglobin of ≤ 11.5 g/dl.
Women who are pregnant or who are breast feeding.
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 surgery during the study.