At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,561 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 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.
Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose (FCM) and Iron Sucrose (Venofer) for Iron Deficiency Anemia and Impaired Renal Function. Completed, enrolled 2,561 participants across 1 site.
Detailed Summary
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia, Impaired Renal Function
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionJul 2011
Study CompletionAug 2011
TodayJul 2026
First PostedSep 22, 2009
Enrollment StartAug 1, 2009
Primary CompletionJul 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.8 years ago
Interventions
Ferric Carboxymaltose (FCM)drug
2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Iron Sucrose (Venofer)drug
5 doses of 200 mg for a total cumulative dose of 1000 mg