CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 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.

Search/NCT01307007
NCT01307007Phase 2Completed
CompareCT.gov

A Randomized, Controlled Study to Investigate the Safety and Explore the Mechanism of Hypophosphatemia With Intravenous Ferric Carboxymaltose (FCM) Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding

American Regent, Inc.·interventional·Posted Mar 2, 2011·Updated Feb 19, 2018

In Brief

A Phase 2 clinical trial evaluating Ferric Carboxymaltose (FCM) and Iron Dextran Injection for Iron Deficiency Anemia. Completed, enrolled 69 participants.

Detailed Summary

The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2011
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2011
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.3 years ago

Interventions

Ferric Carboxymaltose (FCM)drug

15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0

Iron Dextran Injectiondrug

Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.