A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

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-252 was a study evaluating the efficacy and safety of IV ferumoxytol in
pediatric participants with nondialysis-dependent chronic kidney disease.

Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was
combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by
the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age
cohort, with progression from oldest to youngest: Randomization was stratified by the
following age cohorts: 12 to <18 years, 6 to <12 years, 2 to <6 years, and 6 months to <2
years.

Participants who completed the combined AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies had the
option of participating in this extension study.

Key Inclusion Criteria include:

1. Participants who had completed participation in the combined AMAG-FER-CKD-251 and
AMAG-FER-CKD-252 studies within 4 weeks of screening

2. 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

3. 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:

1. Experienced a serious adverse event related to IV iron therapy in the combined
AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies

2. Hemoglobin level ≤7 g/dL