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)

NCT01469078

Phase 1 Completed 18 enrolled Pharmacosmos A/S ClinSmart · collab
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

EvaluationDrugModalityDoseRoute
Comparator Iron isomaltoside 1000 Unknown 100 mg
Comparator Iron isomaltoside 1000 Unknown 200 mg
Comparator Iron isomaltoside 1000 Unknown 500 mg