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

This study has been completed.
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00233597
First received: October 4, 2005
Last updated: February 26, 2009
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 on hemodialysis.


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: Parallel 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 Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

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: 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
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: NCT00233597

  Show 50 Study Locations
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00233597     History of Changes
Other Study ID Numbers: 62745-5
Study First Received: October 4, 2005
Last Updated: February 26, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AMAG Pharmaceuticals, Inc.:
anemia
iron

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferumoxytol
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014