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

This study has been completed.
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00255437
First received: November 17, 2005
Last updated: October 10, 2007
Last verified: October 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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: June 2004
Study Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255437

Locations
United States, Arizona
Phoenix, Arizona, United States, 85012
Tempe, Arizona, United States, 85284
United States, Connecticut
New Haven, Connecticut, United States, 06511
United States, Georgia
Augusta, Georgia, United States, 30901
United States, Illinois
Peoria, Illinois, United States, 61603
United States, Maryland
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Mississippi
Columbus, Mississippi, United States, 39705
United States, Nebraska
Broken Bow, Nebraska, United States, 68822
United States, South Carolina
Greenville, South Carolina, United States, 29605
United States, Virginia
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00255437     History of Changes
Other Study ID Numbers: 62745-7
Study First Received: November 17, 2005
Last Updated: October 10, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Urologic Diseases
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014