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)

PHASE3CompletedINTERVENTIONAL

Enrollment

350

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

April 30, 2014

Study Completion Date

May 31, 2014

Conditions

Non-myeloid MalignanciesChemotherapy Induced Anaemia

Interventions

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

Trial Locations (1)

Apollo Hospitals, New Delhi