CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM) +1 moredrug
Likely dose
Ferric Carboxymaltose (FCM) 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.

Search/NCT01290315
NCT01290315Phase 2Completed
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A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

American Regent, Inc.·interventional·Posted Feb 7, 2011·Updated Feb 8, 2018

In Brief

A Phase 2 clinical trial evaluating Ferric Carboxymaltose (FCM) and Iron Sucrose / Iron Dextran for Iron Deficiency Anemia. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2011
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.4 years ago

Interventions

Ferric Carboxymaltose (FCM)drug

One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)

Iron Sucrose / Iron Dextrandrug

One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)