drugset / Trial / NCT01155388

A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

NCT01155388 ↗

Phase 3 Terminated 14 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Timeline

Start
2011-10-17
Primary completion
2014-06-24
Completion
2014-06-24

Outcome

Outcome not reported

Stopped (Enrollment): “Several factors contributed to significant challenges in enrollment and led the Sponsor to discontinue the AMAG-FER-CKD-252 study as designed.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 3.5 mg/kg Intravenous
Subject Ferumoxytol Diagnostic / imaging agent 7 mg/kg Intravenous
Comparator Oral Iron Unknown 2.5 mg/kg Oral