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A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

RecruitingPhase 3Ages 2 Years - 17 YearsAllAMAG Pharmaceuticals, Inc.
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In plain words

What the trial is, and whether it could suit you

This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: 1. Hemoglobin (Hgb) \<11.0 g/dL AND 2. Any one or more of the following: * Transferrin saturation (TSAT) \<20% * ferritin \<100 ng/mL 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of โ‰ฅ2 clinically significant drug allergies 4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening) 5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg) 6. Hgb โ‰ค7.0 g/dL 7. Serum ferritin level \>600 ng/mL
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What it tests

  • ferumoxytol
  • Iron sucrose
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Where

15 sites
Arkansas Children's Hospital
Little Rock, United States
University of Florida
Gainesville, United States
Optimus U Corporation
Miami, United States
Biomedical Research LLC
Miami, United States
Gwinnett Research Institute
Buford, United States
Sun Research Institute
San Antonio, United States
JSC Saules seimos medicinos centras
Kaunas, Lithuania
Klaipeda Children's Hospital
Klaipฤ—da, Lithuania

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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