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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

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ClinicalTrials.gov Identifier: NCT01114139
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:
To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferumoxytol Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 812 participants
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
Study Start Date : June 2010
Primary Completion Date : February 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Placebo Comparator: Placebo
Normal saline
Other: Placebo
IV Placebo



Primary Outcome Measures :
  1. Hemoglobin changes

Secondary Outcome Measures :
  1. Patient reported outcomes


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

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.

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 Posted: April 30, 2010    Key Record Dates
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