A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

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

Phase

3

Condition

Anemia

Treatment

Iron sucrose

Ferumoxytol

Clinical Study ID

NCT03619850
AMAG-FER-CKD-354
  • Ages 2-17
  • All Genders

Study Summary

Primary Objectives:

To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA

Secondary Objective:

To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

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: a) hemoglobin <12.0 g/dL and b) with either transferrinsaturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk ofdevelopment of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2months and a history of hemoglobin <12 g/dL

  3. Has Chronic Kidney Disease defined as one of the following:

  4. on chronic hemodialysis;

  5. receiving chronic peritoneal dialysis;

  6. estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;

  7. has evidence of structural and/or functional abnormalities e.g., persistentalbuminuria, abnormal urine sediment, electrolyte and other abnormalities dueto tubular disorders for > 3 months.

  8. For patients other than hemodialysis dependent CKD patients, documented history ofunsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or forwhom oral iron is considered medically inappropriate

  9. All subjects (female and male) of childbearing potential who are sexually activemust be on an effective method of birth control for at least 1 month prior to Day 1Dosing and agree to remain on birth control until completion of the study

Exclusion

Exclusion Criteria:

  1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose

  2. History of allergy to intravenous (IV) iron

  3. History of multiple drug allergies (>2)

  4. Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17years <90 mmHg)

  5. Hemoglobin ≤7.0 g/dL

  6. Serum ferritin level >600 ng/mL

Study Design

Total Participants: 129
Treatment Group(s): 2
Primary Treatment: Iron sucrose
Phase: 3
Study Start date:
August 13, 2018
Estimated Completion Date:
August 31, 2024

Study Description

This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose.

Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period.

Subjects receive the following:

• Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later

OR

• Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).

Connect with a study center

  • Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika

    Budapest,
    Hungary

    Active - Recruiting

  • University Of Szeged

    Szeged,
    Hungary

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas,
    Lithuania

    Site Not Available

  • Klaipeda Children's Hospital

    Klaipėda,
    Lithuania

    Site Not Available

  • Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)

    Vilnius,
    Lithuania

    Site Not Available

  • Instituto Mexicano De Trasplantes S.C

    Cuernavaca,
    Mexico

    Active - Recruiting

  • JM Research, SC

    Cuernavaca,
    Mexico

    Site Not Available

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara,
    Mexico

    Active - Recruiting

  • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

    Mexico City,
    Mexico

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku

    Białystok,
    Poland

    Site Not Available

  • Specjalistyczne Gabinety Sp. z o.o

    Kraków,
    Poland

    Site Not Available

  • University Children Hospital

    Kraków,
    Poland

    Site Not Available

  • Polish Mother's Memorial Hospital Research Institute

    Łódź,
    Poland

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • AMAG Pharmaceuticals, Inc.

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

    Bronx, New York 10467
    United States

    Active - Recruiting

  • The Feinstein Institute Medical Research Organization of Northwell Health, Inc.

    Lake Success, New York 11042
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

    New York, New York 10029
    United States

    Site Not Available

  • Akron Nephrology Associates, Inc.

    Akron, Ohio 44302
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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