- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00255437
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
January 7, 2015 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 Chronic Kidney Disease Patients Not on Dialysis
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.
Study Overview
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.
Study Type
Interventional
Enrollment
304
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
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Arizona
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Phoenix, Arizona, United States, 85012
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Tempe, Arizona, United States, 85284
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Connecticut
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New Haven, Connecticut, United States, 06511
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Georgia
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Augusta, Georgia, United States, 30901
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Illinois
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Peoria, Illinois, United States, 61603
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Maryland
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Bethesda, Maryland, United States, 20814
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Michigan
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Detroit, Michigan, United States, 48202
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Mississippi
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Columbus, Mississippi, United States, 39705
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Nebraska
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Broken Bow, Nebraska, United States, 68822
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South Carolina
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Greenville, South Carolina, United States, 29605
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Virginia
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Charlottesville, Virginia, United States, 22908
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Norfolk, Virginia, United States, 23507
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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.
- 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.
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: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The mean change in hemoglobin from baseline.
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Secondary Outcome Measures
Outcome Measure |
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Change in iron indices.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. doi: 10.1159/000087212. Epub 2005 Jul 28.
- Fishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. doi: 10.5414/cn107397.
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
June 1, 2004
Study Completion (ACTUAL)
November 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)
January 9, 2015
Last Update Submitted That Met QC Criteria
January 7, 2015
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62745-7
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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