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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Subjects With Dialysis Dependent Chronic Kidney Disease - NCT01155375-02421(Clinical Trial 687950)



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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 oral iron for the treatment of pediatric subjects with dialysis-dependent chronic kidney disease.
Study summary:
Criteria: Key Inclusion Criteria include: 1. Males or females 6 months to <18 years of age 2. On peritoneal dialysis or hemodialysis for ≥3 months prior to screening 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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