At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 255 enrolled
Drug / intervention
Ferrous Sulfate tablets +1 moredrug
Likely dose
Ferrous Sulfate tablets 325 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.
Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
In Brief
A Phase 3 clinical trial evaluating Ferrous Sulfate tablets and Ferric Carboxymaltose (FCM) for Anemia. Completed, enrolled 255 participants across 1 site.
Detailed Summary
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedApr 2006
Primary CompletionFeb 2007
Study CompletionAug 2007
TodayJul 2026
First PostedApr 24, 2006
Enrollment StartMay 1, 2005
Primary CompletionFeb 1, 2007
Study CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.2 years ago
Interventions
Ferrous Sulfate tabletsdrug
325 mg/TID x 8 weeks
Ferric Carboxymaltose (FCM)drug
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.