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Recruiting NCT03893045

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

Phase III Interventional Iron Deficiency Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ferumoxytol, Iron sucrose.
Who it may be relevant to
Registry conditions: Iron Deficiency Anemia. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Lithuania, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Detailed 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.

Interventions

  • Drug ferumoxytol
    Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
  • Drug Iron sucrose
    Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).

Primary outcome measures

  • Change in Hemoglobin from Baseline to Week 5 [Time frame: 35 days]
Secondary outcome measures (2)
  • Incidence of Treatment Emergent Adverse Events [Time frame: 49 days]
  • Incidence of adverse events of special interest (AESI) [Time frame: 49 days]

Eligibility criteria

Inclusion criteria

  • Male or female 2 years to <18 years of age at time of consent
  • Has IDA defined as:
  • Hemoglobin (Hgb) <11.0 g/dL AND
  • Any one or more of the following:
  • Transferrin saturation (TSAT) <20%
  • ferritin <100 ng/mL
  • 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

  • Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
  • History of allergy to intravenous (IV) iron
  • History of ≥2 clinically significant drug allergies
  • Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
  • Low systolic blood pressure (BP) (age 1 to 9 years <70 + \[age in years x 2\] mmHg, age 10 to 17 years <90 mmHg)
  • Hgb ≤7.0 g/dL
  • Serum ferritin level >600 ng/mL

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Arkansas Children's Hospital — Little Rock
  • University of Florida — Gainesville
  • Optimus U Corporation — Miami
  • Biomedical Research LLC — Miami
  • Gwinnett Research Institute — Buford
  • Sun Research Institute — San Antonio
Poland · 6 centers
  • Osrodek Badan Klinicznych In Vivo sp. z o.o. — Bydgoszcz
  • Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek — Dębica
  • Pro Familia Altera Sp. z o.o. — Katowice
  • Korczowski Bartosz, Gabinet Lekarski — Rzeszów
  • Centrum Zdrowia MDM — Warsaw
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw
Lithuania · 3 centers
  • JSC Saules seimos medicinos centras — Kaunas
  • Klaipeda Children's Hospital — Klaipėda
  • Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos — Vilnius

Identifiers

NCT: NCT03893045 · AMAG-FER-IDA-352

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗