At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 198 enrolled
Drug / intervention
Injectafer +1 moredrug
Likely dose
Injectafer 15mg/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.
Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass
In Brief
A Phase 4 clinical trial evaluating Injectafer and Ferrous Sulfate tablets for Iron Deficiency Anemia Secondary to IBD or Gastric Bypass. Completed, enrolled 198 participants.
Detailed Summary
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedMar 2014
Primary CompletionJul 2016
Study CompletionOct 2017
TodayJul 2026
First PostedMar 13, 2014
Enrollment StartJan 1, 2014
Primary CompletionJul 16, 2016
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.3 years ago
Interventions
Injectaferdrug
2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg
Ferrous Sulfate tabletsdrug
325mg (1 tablet) three times a day for 28 days