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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Iron isomaltoside 1000 | Unknown | 500 mg | Intravenous |
| Comparator | Iron sucrose | Unknown | 200 mg | Intravenous |