drugset / Trial / NCT01469078
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
RandomizedParallel-groupOpen-label
Summary
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
Timeline
- Start
- 2011-10
- Primary completion
- 2012-04
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Iron isomaltoside 1000 | Unknown | 100 mg | — |
| Comparator | Iron isomaltoside 1000 | Unknown | 200 mg | — |
| Comparator | Iron isomaltoside 1000 | Unknown | 500 mg | — |