At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 145 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM)drug
Likely dose
Ferric Carboxymaltose (FCM) 1,000 mgfrom 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.
Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
In Brief
A Phase 3 clinical trial evaluating Ferric Carboxymaltose (FCM) for Anemia. Completed, enrolled 145 participants across 1 site.
Detailed Summary
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedApr 2006
Primary CompletionMar 2007
Study CompletionSep 2007
TodayJul 2026
First PostedApr 24, 2006
Enrollment StartJun 1, 2005
Primary CompletionMar 1, 2007
Study CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.2 years ago
Interventions
Ferric Carboxymaltose (FCM)drug
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit