Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients - Full Text View

Sponsored by:	AMAG Pharmaceuticals, Inc.
Information provided by:	AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00233597

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: ferumoxytol or oral iron	Phase III

MedlinePlus related topics: Anemia Dialysis Kidney Failure

Drug Information available for: Ferumoxytol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:

The mean change in hemoglobin from baseline.

Secondary Outcome Measures:

Change in iron indices.

Estimated Enrollment:	230
Study Start Date:	August 2004
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233597

Show 50 Study Locations

Sponsors and Collaborators

AMAG Pharmaceuticals, Inc.

More Information

National Kidney Foundation This link exits the ClinicalTrials.gov site

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. Epub 2005 Jul 28.

Study ID Numbers:	62745-5
Study First Received:	October 4, 2005
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00233597
Health Authority:	United States: Food and Drug Administration

Keywords provided by AMAG Pharmaceuticals, Inc.:

anemia
iron

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009