CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 296 enrolled
Drug / intervention
Ferumoxytol +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/NCT01227616
NCT01227616Phase 4Completed
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Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis

AMAG Pharmaceuticals, Inc.·interventional·Posted Oct 25, 2010·Updated Apr 21, 2022

In Brief

A Phase 4 clinical trial evaluating Ferumoxytol and Iron Sucrose for Iron Deficiency Anemia Treatment and Chronic Kidney Disease(CKD). Completed, enrolled 296 participants across 43 sites in 3 countries.

Detailed Summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
CountriesCanada, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartAug 1, 2013
Primary CompletionFeb 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.7 years ago

Interventions

Ferumoxytoldrug

IV Ferumoxytol

Iron Sucrosedrug

IV Iron Sucrose