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Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease 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. Identifier: NCT00255424
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : January 9, 2015
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 with chronic kidney disease who are not on dialysis.

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) 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Single Group 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 Chronic Kidney Disease Patients Not on Dialysis
Study Start Date : May 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

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.
  • 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.

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 identifier (NCT number): NCT00255424

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United States, California
Encino, California, United States, 91356
Riverside, California, United States, 92501
Tarzana, California, United States, 91356
United States, Florida
Ocala, Florida, United States, 34471
United States, Louisiana
Shreveport, Louisiana, United States, 71101
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit, Michigan, United States, 48236
United States, New York
Flushing, New York, United States, 11355
Orchard Park, New York, United States, 14127
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Knoxville, Tennessee, United States, 37923
United States, Texas
Houston, Texas, United States, 77074
United States, Virginia
Fairfax, Virginia, United States, 22030
United States, West Virginia
Bluefield, West Virginia, United States, 24701
United States, Wisconsin
Appleton, Wisconsin, United States, 54911
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00255424    
Other Study ID Numbers: 62745-6
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: October 2008
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Ferrosoferric Oxide
Parenteral Nutrition Solutions
Pharmaceutical Solutions