drugset / Trial / NCT01227616

Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

NCT01227616

Phase 4 Completed 296 enrolled AMAG Pharmaceuticals, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Timeline

Start
2013-08
Primary completion
2016-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 510 mg Intravenous
Comparator Iron sucrose Unknown 100 mg Intravenous