Original ResearchClinical—Alimentary TractFERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease
Section snippets
Study Design and Patients
The study was designed as a randomized, controlled, multicenter, open-label trial testing a novel treatment regimen using FCM (Ferinject; Vifor Pharma, Glattbrugg, Switzerland) for noninferiority compared with the Ganzoni-calculated doses of IS (Venofer; Vifor Pharma, Glattbrugg, Switzerland) in patients with IBD and IDA. The study was conducted from October 2008 to December 2009 at 88 hospitals and clinics in 14 countries in accordance with the Declaration of Helsinki and Good Clinical
Patient Characteristics
A total of 880 patients were screened; 485 were randomized. Most common screening failures were not meeting the inclusion or exclusion criteria (361 patients, 91.4%). Two patients did not participate because of the projected number of IS injections. Details of patient disposition to treatment arms and populations analyzed are summarized in a CONSORT diagram (Figure 1). No differences were observed in patient demographics, type and history of IBD, and laboratory measures between the treatment
Discussion
This study is the largest study to date addressing IDA in IBD. It showed that patients with IDA secondary to IBD responded significantly better to FCM with its simplified dose regimen than to the Ganzoni-calculated IS dose regimen. The FCM regimen resulted in Hb normalization in 73% of patients, and almost twice as many FCM-treated patients responded with normalization of both Hb and ferritin than in the IS group (31% vs 17%). Disease-related (IBDQ) physical and mental quality of life (SF-36)
Acknowledgments
The authors thank all investigators at all study sites (see Appendix), the support in funding and conducting the study (Barbara von Eisenhart Rothe, responsible Medical Director; Janne Harjunpää, statistical analysis; Vifor Pharma, Switzerland), and medical writing support (Walter Fürst; SFL Regulatory Affairs & Scientific Communication, Switzerland).
The corresponding author had full access to all of the data and takes full responsibility for the veracity of the data and statistical analysis.
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Conflicts of interest The authors disclose the following: Philippe Marteau: Speakers honoraria from Vifor International. Tariq Iqbal: Speakers honoraria from Vifor International. Jürgen Stein: Consultancy and speakers honoraria from Vifor International. Florian S. Gutzwiller: Research funding from Vifor International. Lise Riopel: Employee Vifor Pharma, Switzerland. Christoph Gasche: received grant and consultancy honoraria from Vifor International, Pharmacosmos A/S, Fresenius Medical Care, Renapharma Sweden.
The remaining authors disclose no conflicts.
Funding Supported by Vifor Pharma, Switzerland, which sponsored this study and supported the development of the study design and preparation of the manuscript; and by Parexel International, Germany, an independent clinical research organization that conducted the trial and performed the statistical analysis.
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