Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

AMAG Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Anemia

Treatments

Drug: ferumoxytol or oral iron

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233597

62745-5

Details and patient eligibility

About

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients ≥18 years.
Chronic hemodialysis.
Stable supplemental EPO therapy.
Baseline hemoglobin of ≤ 11.5 g/dl.

Exclusion criteria

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.
Patients with active infections.
Recent blood transfusions.
Patients with known allergies to iron products.