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)

{ "Ferumoxytol for Iron Deficiency Anemia in Children with Chronic Kidney Disease", "This study is looking at two medicines, ferumoxytol and iron sucrose, to treat iron deficiency anemia (low iron in the blood) in children aged 2 to 17 years who also have chronic kidney disease (CKD). Researchers want to see if ferumoxytol is safe and works as well as iron sucrose. They will also study how ferumoxytol moves through the body. To join, children need to have low hemoglobin (a protein in red blood cells) and either low transferrin saturation (TSAT) or low ferritin (proteins that store iron). The study aims to see if hemoglobin levels increase by at least 0.5 g/dL by Week 5. About 129 children are expected to participate, but the current status of the study is unclear.", "design": "This is a Phase 3, randomized, open-label study involving about 129 participants. Participants will be randomly assigned to receive either ferumoxytol or iron sucrose.", "commitments": "Total participation in the study will be up to 7 weeks, including a 2-week screening period and a 5-week treatment period. Participants will receive two intravenous (IV) infusions of ferumoxytol or multiple doses of iron sucrose, depending on their kidney disease status.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoint for measuring success is at Week 5 (35 days) after starting treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03619850

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)

Recruiting
PHASE3Ages 2–17InterventionalTreatment
AMAG Pharmaceuticals, Inc.
~129 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:FerumoxytolIron sucrose

At a glance

Recruiting sites
9 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5
Measured over 35 days
Chronic Kidney Disease; Iron Deficiency Anemia

NCT03619850

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Akron Nephrology Associates, Inc.

    Akron, Ohiono site contact published

    Recruiting

  • Children's Mercy Hospital

    Kansas City, Missourino site contact published

    Recruiting

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Mexicono site contact published

    Recruiting

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, Lithuaniano site contact published

    Not yet recruiting

  • Instituto Mexicano De Trasplantes S.C

    Cuernavaca, Mexicono site contact published

    Recruiting

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

    Mexico City, Mexicono site contact published

    Recruiting

  • Memorial Healthcare System

    Hollywood, Floridano site contact published

    Not yet recruiting

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

    The Bronx, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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  • Hemoglobin change of at least 0.5 g/dL from Baseline to Week 535 days

    Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5