Tests ferumoxytol against iron sucrose for anemia in children with kidney disease
Compares ferumoxytol with iron sucrose for low iron anemia in children with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Vilnius, LithuaniaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 17 years old?
Source: NCT03619850, who can take part
Where in Lithuania
- Vilniaus universiteto ligonine Santaros klinikos VšĮVilnius, LithuaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AMAG Pharmaceuticals, Inc.
- Trial code
- NCT03619850EU 2024-516263-92-00
- Record updated
- 17 April 2026
- Original description
Primary Objectives:Read full original descriptionShow less
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)
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.
Inclusion: Male or female 2 years to <18 years of age at time of consent; 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; Has Chronic Kidney Disease defined as one of the following:; on chronic hemodialysis; receiving chronic peritoneal dialysis; estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2; 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; 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; 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: Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose; History of allergy to intravenous (IV) iron; History of multiple drug allergies (>2); Hemoglobin ≤7.0 g/dL; Serum ferritin level >600 ng/mL; Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg).