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

Description

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).

Conditions

Iron Deficiency Anemia

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Study Overview

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Study Details

Study overview

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).

A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

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

Condition
Iron Deficiency Anemia
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Gainesville

University of Florida, Gainesville, Florida, United States, 32608

Miami

Optimus U Corporation, Miami, Florida, United States, 33125

Miami

Biomedical Research LLC, Miami, Florida, United States, 33184

Buford

Gwinnett Research Institute, Buford, Georgia, United States, 30519

San Antonio

Sun Research Institute, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
  • 2. History of allergy to intravenous (IV) iron
  • 3. History of ≥2 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 ≤7.0 g/dL
  • 7. Serum ferritin level \>600 ng/mL

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AMAG Pharmaceuticals, Inc.,

Study Record Dates

2025-10