Evaluating ferumoxytol for treating iron deficiency anemia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized, open-label study involves pediatric subjects aged 2 to less than 18 years with iron deficiency anemia (IDA). Participants will be randomly assigned to receive either ferumoxytol or iron sucrose, with treatment regimens designed to assess the efficacy and safety of these interventions. The study will monitor hemoglobin levels and adverse events over a period of five weeks following treatment. The aim is to determine the effectiveness of ferumoxytol compared to traditional iron sucrose therapy in this population.

Why it matters

Who can join: the full rules

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 ≥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

Where it's running

• Optimus U Corporation
  Miami, Florida, United States Recruiting
• Biomedical Research LLC
  Miami, Florida, United States Recruiting
• Sun Research Institute
  San Antonio, Texas, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Not yet recruiting
• University of Florida
  Gainesville, Florida, United States Not yet recruiting
• Gwinnett Research Institute
  Buford, Georgia, United States Not yet recruiting

Study contacts

• Study coordinator: Clinical Trial Interest
• Email: CTInterest@covispharma.com
• Phone: 1-877-374 -4177

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.