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

April 1, 2022 updated by: AMAG Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
      • Tempe, Arizona, United States, 85284
    • California
      • Los Angeles, California, United States, 90073
      • Mountain View, California, United States, 94014
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Hudson, Florida, United States, 34667
      • Tampa, Florida, United States, 33614
    • Georgia
      • Augusta, Georgia, United States, 30901
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Gurnee, Illinois, United States, 60081
      • Hines, Illinois, United States, 60141
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
    • Maryland
      • Bethesda, Maryland, United States, 20814
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Detroit, Michigan, United States, 48236
      • Detroit, Michigan, United States, 48202
    • Mississippi
      • Columbus, Mississippi, United States, 39705
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63110
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Brooklyn, New York, United States, 11203
      • Brooklyn, New York, United States, 11212
      • Brooklyn, New York, United States, 11238
      • Flushing, New York, United States, 11355
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10016
      • New York, New York, United States, 10128
      • Orchard Park, New York, United States, 14127
      • Springfield Gardens, New York, United States, 11413
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Lewistown, Pennsylvania, United States, 17044
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • Sumter, South Carolina, United States, 29150
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
      • Memphis, Tennessee, United States, 38104
    • Texas
      • Austin, Texas, United States, 78758
      • Corpus Christi, Texas, United States, 78411
      • Dallas, Texas, United States, 75216
      • Dallas, Texas, United States, 75240
      • Houston, Texas, United States, 77099
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Chesapeake, Virginia, United States, 23320
      • Fairfax, Virginia, United States, 22030
      • Norfolk, Virginia, United States, 23507
      • Salem, Virginia, United States, 24153
    • Washington
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The mean change in hemoglobin from baseline.

Secondary Outcome Measures

Outcome Measure
Change in iron indices.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMAG Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 4, 2005

First Posted (ESTIMATE)

October 6, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62745-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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