At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 350 enrolled
Drug / intervention
iron isomaltoside 1000 +1 moredrug
Likely dose
iron isomaltoside 1000 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating iron isomaltoside 1000 and iron sulphate for Non-myeloid Malignancies and Chemotherapy Induced Anaemia. Completed, enrolled 350 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartOct 2010
Primary CompletionApr 2014
Study CompletionMay 2014
TodayJul 2026
First PostedJun 16, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.0 years ago
Interventions
iron isomaltoside 1000drug
intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
iron sulphatedrug
oral, 200 mg per day (100 mg bid),12 weeks