CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 79 enrolled
Drug / intervention
Ferric carboxymaltose +1 moredrug
Likely dose
Not stated in 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/NCT03523117
NCT03523117Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia

American Regent, Inc.·interventional·Posted May 14, 2018·Updated Jun 22, 2022

In Brief

A Phase 3 clinical trial evaluating Ferric carboxymaltose and Ferrous Sulfate for Iron Deficiency Anemia. Completed, enrolled 79 participants across 16 sites.

Detailed Summary

The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 14, 2018
Enrollment StartJan 31, 2019
Primary CompletionDec 22, 2020
Study CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.1 years ago

Interventions

Ferric carboxymaltosedrug

Intravenous iron

Ferrous Sulfatedrug

oral iron therapy