Status:
TERMINATED
A Trial of Ferumoxytol for the 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 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-251 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Study AMAG-FER-CKD-252 (NCT01155388) was a study evaluati...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:
- Males or females 6 months to \<18 years of age
- CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
- Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level \<100 nanograms/milliliter (ng/mL)
- Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study
- Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:
- History of allergy to either oral or IV iron
- Hemoglobin level ≤7.0 g/dL
- Serum ferritin level \>600 ng/mL
- Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
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
NCT01155375
Start Date
October 17 2011
End Date
June 24 2014
Last Update
April 4 2022
Active Locations (1)
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1
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451