drugset / Trial / NCT02130063
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
Phase 3
Completed
511 enrolled
Pharmacosmos A/S
BioStata · collabClinStar, LLC · collabLaboratory Corporation of America · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Timeline
- Start
- 2014-05
- Primary completion
- 2015-08
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iron isomaltoside 1000 | Unknown | — | Intravenous |
| Comparator | Iron sucrose | Unknown | — | Intravenous |