Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

This study has been completed.

First Received: November 17, 2005 Last Updated: October 21, 2008 History of Changes

Sponsored by:	AMAG Pharmaceuticals, Inc.
Information provided by:	AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00255424

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group 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 Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Ferumoxytol

U.S. FDA Resources

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:	304
Study Start Date:	May 2004
Study Completion Date:	August 2006

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.

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255424

Locations

United States, California

Riverside, California, United States, 92501

Encino, California, United States, 91356

Tarzana, California, United States, 91356
United States, Florida

Ocala, Florida, United States, 34471
United States, Louisiana

Shreveport, Louisiana, United States, 71101

Shreveport, Louisiana, United States, 71103
United States, Massachusetts

Springfield, Massachusetts, United States, 01107
United States, Michigan

Detroit, Michigan, United States, 48236
United States, New York

Flushing, New York, United States, 11355

Orchard Park, New York, United States, 14127
United States, Ohio

Columbus, Ohio, United States, 43210
United States, Pennsylvania

Hershey, Pennsylvania, United States, 17033

Lancaster, Pennsylvania, United States, 17604
United States, Tennessee

Chattanooga, Tennessee, United States, 37404

Knoxville, Tennessee, United States, 37923
United States, Texas

Houston, Texas, United States, 77074
United States, Virginia

Fairfax, Virginia, United States, 22030
United States, West Virginia

Bluefield, West Virginia, United States, 24701
United States, Wisconsin

Appleton, Wisconsin, United States, 54911

Sponsors and Collaborators

AMAG Pharmaceuticals, Inc.

More Information

Additional Information:

National Kidney Foundation This link exits the ClinicalTrials.gov site

Publications:

Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. Epub 2008 Jun 4.

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:	62745-6
Study First Received:	November 17, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00255424 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic
Anemia

Kidney Failure, Chronic
Kidney Diseases
Iron
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Anemia
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 02, 2009