At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 161 enrolled
Drug / intervention
Ferric Carboxymaltose +1 moredrug
Likely dose
Ferric Carboxymaltose 15 mg/kgfrom 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 Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose and Iron Dextran for Anemia. Completed, enrolled 161 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionJan 2010
Study CompletionMar 2011
TodayJul 2026
First PostedJun 24, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.0 years ago
Interventions
Ferric Carboxymaltosedrug
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
Iron Dextrandrug
As determined by the investigator to a maximum cumulative dose of 2,250 mg.