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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114139
First Posted: April 30, 2010
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
  Purpose
To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Condition Intervention Phase
Iron Deficiency Anemia Drug: Ferumoxytol Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Hemoglobin changes

Secondary Outcome Measures:
  • Patient reported outcomes

Enrollment: 812
Study Start Date: June 2010
Study Completion Date: October 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Placebo Comparator: Placebo
Normal saline
Other: Placebo
IV Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. Subjects with IDA
  3. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
  4. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

  1. History of allergy to IV iron
  2. Allergy to two or more classes of drugs
  3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
  4. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
  5. Hemoglobin ≤7.0 g/dL
  6. Serum ferritin >600 ng/mL
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114139


Locations
United States, Massachusetts
AMAG Pharmaceuticals, Inc.
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01114139     History of Changes
Other Study ID Numbers: AMAG-FER-IDA-301
First Submitted: April 29, 2010
First Posted: April 30, 2010
Last Update Posted: June 6, 2013
Last Verified: May 2013

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
Feraheme
ferumoxytol
AUB
cancer
GI disorders
postpartum anemia
The treatment of iron deficiency anemia (IDA)

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Deficiency Diseases
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrosoferric Oxide
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions