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

Last updated: August 9, 2024
Sponsor: AMAG Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Anemia

Treatment

Iron sucrose

ferumoxytol

Clinical Study ID

NCT03893045
AMAG-FER-IDA-352
  • Ages 2-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female 2 years to <18 years of age at time of consent

  2. Has IDA defined as:

  3. Hemoglobin (Hgb) <11.0 g/dL AND

  4. Any one or more of the following:

  • Transferrin saturation (TSAT) <20%
  • ferritin <100 ng/mL
  1. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannotbe tolerated, or for whom oral iron is considered medically inappropriate

Exclusion

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 ≥2 clinically significant drug allergies

  4. Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement forchronic 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

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Iron sucrose
Phase: 3
Study Start date:
September 18, 2019
Estimated Completion Date:
October 31, 2025

Study Description

Subjects will be randomized to treatment in a 2:1 ratio (ferumoxytol: iron sucrose) and stratified by age group (2 to <6 years; 6 to <12 years; and 12 to <18 years). Subjects will receive one of the following treatment regimens:

• Ferumoxytol: 7 mg Fe/kg IV (maximum 510 mg/dose) x 2 doses, the first dose administered on Day 1 and the second 2 to 8 days later.

OR

• Iron sucrose (Venofer®): 4 mg Fe/kg IV (maximum 200 mg/dose) x 5 doses, the first dose on Day 1 and subsequent doses administered at least once per week and up to 3 times/week. All subjects will be monitored at the study site through at least 1 hour after the completion of each infusion of study drug. Assessment of blood Hgb concentrations, adverse events, and other safety assessments will be performed through study Week 5.

Connect with a study center

  • JSC Saules seimos medicinos centras

    Kaunas,
    Lithuania

    Site Not Available

  • Klaipeda Children's Hospital

    Klaipėda,
    Lithuania

    Site Not Available

  • Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos

    Vilnius,
    Lithuania

    Site Not Available

  • Osrodek Badan Klinicznych In Vivo sp. z o.o.

    Bydgoszcz,
    Poland

    Site Not Available

  • Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek

    Debica,
    Poland

    Site Not Available

  • Pro Familia Altera Sp. z o.o.

    Katowice,
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów,
    Poland

    Site Not Available

  • Centrum Zdrowia MDM

    Warsaw,
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wrocław,
    Poland

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Biomedical Research LLC

    Miami, Florida 33184
    United States

    Active - Recruiting

  • Optimus U Corporation

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Gwinnett Research Institute

    Buford, Georgia 30519
    United States

    Site Not Available

  • AMAG Pharmaceuticals, Inc.

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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