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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia - NCT01114139-02421(Clinical Trial 622865)



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City:  Lexington
State:  
MA
Zip Code: 02421
Conditions: Iron Deficiency Anemia
Purpose: To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).
Study summary:
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
Study is available at: AMAG Pharmaceuticals, Inc.
Lexington, MA 02421
United States

Primary Contact:
Carol Lewis-Cullinan
Email: idastudyinfo@amagpharma.com
Phone: 617-498-3362
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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