A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01114139
First received: April 29, 2010
Last updated: May 29, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported outcomes [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01114139

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

No publications provided by AMAG Pharmaceuticals, Inc.

Additional 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
Study First Received: April 29, 2010
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Hungary: Ministry of Health, Social and Family Affairs
India: Central Drugs Standard Control Organization
Latvia: State Agency of Medicines
Poland: Ministry of Health

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
Deficiency Diseases
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Malnutrition
Metabolic Diseases
Nutrition Disorders
Ferrosoferric Oxide
Hematinics
Hematologic Agents
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014