At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 626 enrolled
Drug / intervention
FCM (Ferric carboxymaltose) high ferritin target +2 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.
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease
In Brief
A Phase 3 clinical trial evaluating FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, and 1 other intervention for Iron Deficiency Anaemia and Chronic Kidney Disease. Completed, enrolled 626 participants across 19 sites in 19 countries.
Detailed Summary
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anaemia, Chronic Kidney Disease
CountriesAustralia, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
CollaboratorsAmerican Regent, Inc., ICON Clinical Research
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartDec 2009
Primary CompletionFeb 2013
Study CompletionFeb 2014
TodayJul 2026
First PostedOct 14, 2009
Enrollment StartDec 1, 2009
Primary CompletionFeb 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.7 years ago
Interventions
FCM (Ferric carboxymaltose) high ferritin targetdrug
FCM (Ferric carboxymaltose) low ferritin targetdrug
Oral Iron (Ferrous sulphate)drug