Status:
TERMINATED
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Conditions:
Iron Deficiency Anemia
Nondialysis-dependent Chronic Kidney Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).
Detailed Description
Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evalu...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for this study include:
- Males or females 6 months to \<18 years of age
- Nondialysis dependent CKD, including kidney transplant recipients
- Has iron deficiency anemia defined as: a) hemoglobin level \<11.0 grams (g)/deciliter (dL) and b) transferrin saturation level \<20%
- Female participants 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 for this study include:
- History of allergy to either oral or IV iron
- Allergy to two or more classes of drugs
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
- Hemoglobin level ≤7.0 g/dL
- Serum ferritin level \>600 nanograms/milliliter
Exclusion
Key Trial Info
Start Date :
October 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01155388
Start Date
October 17 2011
End Date
June 24 2014
Last Update
April 28 2022
Active Locations (1)
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1
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451