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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00233597
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : April 4, 2022
Information provided by:
AMAG Pharmaceuticals, Inc.

Brief Summary:
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 Intervention/treatment Phase
Anemia Drug: ferumoxytol or oral iron Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy
Study Start Date : August 2004
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis Iron

Primary Outcome Measures :
  1. The mean change in hemoglobin from baseline.

Secondary Outcome Measures :
  1. Change in iron indices.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233597

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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Additional Information:
Publications of Results:
Other Publications:
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ClinicalTrials.gov Identifier: NCT00233597    
Other Study ID Numbers: 62745-5
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Keywords provided by AMAG Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Hematologic Diseases
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions