drugset
drugset / Trial / NCT01102413

Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

NCT01102413 ↗

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

Summary

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).

Timeline

Start
2010-04
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Iron Sulfate Small molecule — Oral
Subject Iron isomaltoside 1000 Unknown — Intravenous

Indications

chronic kidney disease iron deficiency anemia