NCT01102413

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

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Iron Deficiency Anemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Monofer	Infusion or injections
DRUG	Iron Sulphate	Oral intake

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-04-13
• Last updated: 2015-12-03
• Results posted: 2015-12-03

Locations

1 site across 1 country: Denmark