At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 735 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 a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose and Standard Medical Care (SMC) for Anemia. Completed, enrolled 735 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 CompletionJul 2009
Study CompletionMar 2011
TodayJul 2026
First PostedJun 24, 2008
Enrollment StartJun 1, 2008
Primary CompletionJul 1, 2009
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.0 years ago
Interventions
Ferric Carboxymaltosedrug
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Standard Medical Care (SMC)drug
Per product label