drugset / Trial / NCT01222884

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

NCT01222884

Phase 3 Completed 351 enrolled Pharmacosmos A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Timeline

Start
2011-06
Primary completion
2013-10
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron isomaltoside 1000 Unknown 500 mg Intravenous
Comparator Iron sucrose Unknown 200 mg Intravenous