CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,025 enrolled
Drug / intervention
Injectafer +1 moredrug
Likely dose
Injectafer 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/NCT01950247
NCT01950247Phase 4Completed
CompareCT.gov

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on QOL and Resource Utilization, of Injectafer® vs. IV Iron Standard of Care for the Treatment of IDA in an Infusion Center

American Regent, Inc.·interventional·Posted Sep 25, 2013·Updated May 22, 2025

In Brief

A Phase 4 clinical trial evaluating Injectafer and SOC for Iron Deficiency Anemia (IDA). Completed, enrolled 1,025 participants.

Detailed Summary

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2013
Enrollment StartAug 15, 2013
Primary CompletionMay 20, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago

Interventions

Injectaferdrug

2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.

SOCdrug