A Crossover Safety Study of Ferumoxytol Versus Placebo

November 10, 2008 updated by: AMAG Pharmaceuticals, Inc.

A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo

This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.

Study Type

Interventional

Enrollment

750

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
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85012
    • California
      • Mountain View, California, United States, 94041
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • District of Columbia
      • Washington, District of Columbia, United States, 20854
    • Florida
      • Ocala, Florida, United States, 34471
      • Tampa, Florida, United States, 33614
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Augusta, Georgia, United States, 30901
      • Newman, Georgia, United States, 30265
    • Illinois
      • Peoria, Illinois, United States, 61603
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Bethesda, Maryland, United States, 20814
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
    • Michigan
      • Detroit, Michigan, United States, 48236
    • Missouri
      • St. Louis, Missouri, United States, 63136
    • Nebraska
      • Broken Bow, Nebraska, United States, 68822
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New York
      • Flushing, New York, United States, 11355
      • New York, New York, United States, 10016
      • New York, New York, United States, 10029
      • Orchard Park, New York, United States, 14127
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16176
      • Lancaster, Pennsylvania, United States, 17604
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • Sumter, South Carolina, United States, 29150
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Knoxville, Tennessee, United States, 37923
    • Texas
      • Austin, Texas, United States, 78758
      • Houston, Texas, United States, 77074
      • San Antonio, Texas, United States, 78212
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Charlottesville, Virginia, United States, 22908
      • Chesapeake, Virginia, United States, 23320
      • Norfolk, Virginia, United States, 23507
    • West Virginia
      • Bluefield, West Virginia, United States, 24701
    • 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.
  • Have chronic kidney disease per K/DOQI guidelines.
  • Baseline hemoglobin of > 9.0 and < 12.5 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 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: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.

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

January 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 10, 2008

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62745-8

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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