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A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia


Phase 3
18 Years
N/A
Not Enrolling
Both
Iron Deficiency Anemia

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Trial Information

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Hemoglobin changes

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

AMAG-FER-IDA-301

NCT ID:

NCT01114139

Start Date:

June 2010

Completion Date:

October 2012

Related Keywords:

  • Iron Deficiency Anemia
  • Iron deficiency anemia
  • Feraheme
  • ferumoxytol
  • AUB
  • cancer
  • GI disorders
  • postpartum anemia
  • The treatment of iron deficiency anemia (IDA)
  • Anemia
  • Deficiency Diseases
  • Anemia, Iron-Deficiency

Name

Location

AMAG Pharmaceuticals, Inc.Lexington, Massachusetts  02421