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Evaluating ferumoxytol for treating iron deficiency anemia in children with chronic kidney disease

A Phase 3, Randomized, Open-Label, Multicenter 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)

Phase 3 Interventional AMAG Pharmaceuticals, Inc. · NCT03619850

This study is testing whether a new iron treatment called ferumoxytol can help children with chronic kidney disease and iron deficiency anemia feel better compared to a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment129 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorAMAG Pharmaceuticals, Inc. Industry-sponsored
Locations21 sites (Hollywood, Florida and 20 other locations)
Trial IDNCT03619850 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial aims to assess the safety and efficacy of ferumoxytol compared to iron sucrose in pediatric patients suffering from iron deficiency anemia (IDA) associated with chronic kidney disease (CKD). The study will involve approximately 125 participants who will be randomized to receive either ferumoxytol or iron sucrose over a treatment period of 5 weeks, following a 2-week screening phase. The trial will also evaluate the pharmacokinetics and pharmacodynamics of ferumoxytol in this population. Participants will receive two intravenous infusions of ferumoxytol or a series of iron sucrose doses based on their dialysis status.

Who should consider this trial

Good fit: Ideal candidates include children aged 2 to under 18 years with iron deficiency anemia and chronic kidney disease.

Not a fit: Patients who do not have iron deficiency anemia or chronic kidney disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for pediatric patients with iron deficiency anemia and chronic kidney disease.

How similar studies have performed: Other studies have shown promising results with ferumoxytol in adult populations, but this specific application in pediatric CKD patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin \<12 g/dL
3. Has Chronic Kidney Disease defined as one of the following:

   1. on chronic hemodialysis;
   2. receiving chronic peritoneal dialysis;
   3. estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2;
   4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \> 3 months.
4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study

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 10-17 years \<90 mmHg)
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin level \>600 ng/mL

Where this trial is running

Hollywood, Florida and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseaseIron Deficiency AnemiaIron deficiency anemiachronic kidney diseasepediatricsferumoxytoliron sucroseFeraheme
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.