NCT01145638

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Pharmacosmos A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

Conditions

• Non-myeloid Malignancies
• Chemotherapy Induced Anaemia

Interventions

Type	Name	Description
DRUG	iron isomaltoside 1000	intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
DRUG	iron sulphate	oral, 200 mg per day (100 mg bid),12 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2010-06-16
• Last updated: 2015-12-03
• Results posted: 2015-12-03

Locations

1 site across 1 country: India