A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Iron Deficiency Anemia
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia, Feraheme, ferumoxytol, CKD, pediatric, dialysis-dependent, nondialysis-dependent
Eligibility Criteria
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
Sites / Locations
- AMAG Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ferumoxytol
Oral Iron
Participants will receive 1 of the following 2 ferumoxytol dose regimens: Four IV injections of ferumoxytol 3.5 mg Fe/kg (maximum of 255 mg/dose) administered on nonconsecutive days within a 14-day period as follows: Day 1 (dose 1), Days 3* through 10 (dose 2), Days 5 through 12 (dose 3), and Days 7 through 14 (dose 4). *Participants participating in PK sampling received the second dose on Day 4 after the 72-hour PK sample was collected. Two IV injections of ferumoxytol 7.0 mg Fe/kg (maximum of 510 mg/dose), the first administered on Day 1 and the second on Days 3 through 9.
Participants will receive oral iron 2.5 mg Fe/kg twice daily (maximum of 100 mg/dose) on Days 1 through 35.