Ferinject for Correction of Anemia in Patients With IBD (FER-IBD-COR)

Tracking Information

Start Date  ICMJEOctober 2008
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)
Number of responders [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryNo Changes Posted
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)
  • Adverse events: type, nature, incidence and outcome. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in disease activity (CDAI, CAI, C-reactive protein [CRP]). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in different iron paramenters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEFerinject for Correction of Anemia in Patients With IBD
Official Title  ICMJE 
Brief Summary

The aim of the study is to evaluate the efficacy and safety of a new dosage regimen of FERINJECT® compared with a well established intravenous iron treatment.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Inflammatory Bowel Disease
  • Anemia
  • Iron Deficiency
Intervention  ICMJEDrug: Intravenous iron
Intravenous infusion
Study Arms / Comparison Groups
  • Ferinject: Experimental
    Intervention: Drug: Intravenous iron
  • Venofer: Active Comparator
    Intervention: Drug: Intravenous iron

Recruitment Information

Estimated Enrollment  ICMJE420
Completion Date 
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anemic patients with iron deficiency anemia suffering from IBD
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Anna Ivleva Sauerborn, MD+41 588518493anna.ivleva@vifor.com
Location Countries  ICMJERussian Federation

Administrative Information