Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-27 @ 11:18 AM
Study NCT ID:
NCT00810004
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2008-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance Treatment of Iron Deficiency in IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 245}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2008-12-16', 'studyFirstSubmitQcDate': '2008-12-16', 'lastUpdatePostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of maintenance treatment of iron deficiency', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Deficiency', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '23078888', 'type': 'DERIVED', 'citation': 'Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77. doi: 10.1016/j.cgh.2012.10.013. Epub 2012 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nNon-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.\n\nFemales of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.\n\nExclusion Criteria:\n\nChronic alcohol abuse (alcohol consumption \\>20 g/day).\n\nPresence of portal hypertension with oesophageal varices. History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.\n\nKnown hypersensitivity to FERINJECT®.\n\nHistory of acquired iron overload.\n\nMyelodysplastic syndrome.\n\nPregnancy or lactation.\n\nKnown active infection, clinically significant overt bleeding, active malignancy. Known chronic renal failure.\n\nSurgery with relevant blood loss (defined as Hb drop \\<2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.\n\nChronic liver disease or increase of liver enzymes (alanine aminotransferase (\\[ALT\\], aspartate aminotransferase \\[AST\\]) \\>3 times the upper limit of normal range.\n\nKnown human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n\nInability to fully comprehend and/or perform study procedures in the investigator's opinion.\n\nParticipation in any other interventional study (except correction study) within 1 month prior to screening.\n\nBody weight \\<35 kg.\n\nSignificant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator."}, 'identificationModule': {'nctId': 'NCT00810004', 'acronym': 'FER-IBD-MAIN', 'briefTitle': 'Maintenance Treatment of Iron Deficiency in IBD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT®) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'FERGI-MAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferinject', 'description': 'Intravenous infusion of iron', 'interventionNames': ['Drug: Ferinject']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'NaCL 0,9%', 'interventionNames': ['Drug: Ferinject']}], 'interventions': [{'name': 'Ferinject', 'type': 'DRUG', 'description': 'Intravenous infusion of iron', 'armGroupLabels': ['Ferinject', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'State Scientific Center of Coloproctology of RosMedTekhnolgy', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Christoph Gasche, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}