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

NCT ID: NCT00233597

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ferumoxytol or oral iron

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Los Angeles, California, United States

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Mountain View, California, United States

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New Haven, Connecticut, United States

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Hudson, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Honolulu, Hawaii, United States

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Gurnee, Illinois, United States

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Hines, Illinois, United States

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Baton Rouge, Louisiana, United States

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Bethesda, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Columbus, Mississippi, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Flushing, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Springfield Gardens, New York, United States

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Chapel Hill, North Carolina, United States

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Portland, Oregon, United States

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Lewistown, Pennsylvania, United States

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Greenville, South Carolina, United States

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Sumter, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Alexandria, Virginia, United States

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Chesapeake, Virginia, United States

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Fairfax, Virginia, United States

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Norfolk, Virginia, United States

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Salem, Virginia, United States

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Spokane, Washington, United States

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Appleton, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16088081 (View on PubMed)

Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.

Reference Type RESULT
PMID: 19176796 (View on PubMed)

Related Links

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http://www.kidney.org/index.cfm

National Kidney Foundation

Other Identifiers

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62745-5

Identifier Type: -

Identifier Source: org_study_id

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