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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Nondialysis-Dependent Chronic Kidney Disease - NCT01155388-02421(Clinical Trial 687951)



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City:  Lexington
State:  
MA
Zip Code: 02421
Conditions: Iron Deficiency Anemia - Nondialysis Dependent Chronic Kidney Disease
Purpose: To evaluate the efficacy and safety of IV ferumoxytol compared with oral iron for the treatment of pediatric subjects with nondialysis-dependent chronic kidney disease.
Study summary:
Criteria: Key Inclusion Criteria include: 1. Males or females 6 months to <18 years of age 2. Nondialysis dependent CKD, including kidney transplant recipients 3. 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. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test 4. Hemoglobin ≤7.0 g/dL 5. Serum ferritin >600 ng/mL
Study is available at: AMAG Pharmaceuticals, Inc.
Lexington, MA 02421
United States

Primary Contact:
Christine Tosone
Email: pedstudyinfo@amagpharma.com
Phone: 617-498-2893
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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