Status:
TERMINATED
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron...
Detailed Description
Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of intravenous (IV) ferumoxytol in pediatric participants with dialysis-dependent chronic kidney disease (CKD). Study AMAG-FER-CKD...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria include:
- Participants who had completed participation in the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies within 4 weeks of screening
- Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
- Participant and/or legal guardian is capable of understanding and complying with the protocol requirements and is available for the duration of the study
- Key Exclusion Criteria include:
- Experienced a serious adverse event related to IV iron therapy in the combined AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies
- Hemoglobin level ≤7 g/dL
Exclusion
Key Trial Info
Start Date :
December 27 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01264679
Start Date
December 27 2011
End Date
April 24 2015
Last Update
April 28 2022
Active Locations (1)
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1
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451