drugset / Trial / NCT03893045

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

NCT03893045

Phase 3 Recruiting 75 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2019-09-18
Primary completion
2026-07
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 7 mg/kg Intravenous
Comparator Iron sucrose Unknown 4 mg/kg Intravenous