Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT00255593
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2005-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Rituximab in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-29', 'studyFirstSubmitDate': '2005-11-18', 'studyFirstSubmitQcDate': '2005-11-18', 'lastUpdatePostDateStruct': {'date': '2007-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of biopsyproven rejection, graft loss or death during the first 6 months following transplanation'}], 'secondaryOutcomes': [{'measure': 'Renal function at 6 months'}, {'measure': 'Incidence of infections'}, {'measure': 'Incidence of rituximab-related adverse events'}, {'measure': 'Incidence of malignancies'}]}, 'conditionsModule': {'keywords': ['Kidney', 'Transplantation', 'Immunosuppression', 'Rituximab'], 'conditions': ['Renal Transplantation']}, 'referencesModule': {'references': [{'pmid': '16925569', 'type': 'RESULT', 'citation': 'Genberg H, Hansson A, Wernerson A, Wennberg L, Tyden G. Pharmacodynamics of rituximab in kidney allotransplantation. Am J Transplant. 2006 Oct;6(10):2418-28. doi: 10.1111/j.1600-6143.2006.01497.x. Epub 2006 Aug 21.'}]}, 'descriptionModule': {'briefSummary': 'Current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-lymphocyte mediated processes. However there is an increasing evidence to suggest that B-lymphocytes have a role in the otherwise classic T-cell mediated rejection of transplants by there ability to act as antigen presenting cells and T-cell activators. Thus there is a significant medical need for effective therapies targeting B cells of transplant patients.One such potential therapy would be to use rituximab, a monoclonal antibody against B-cells in all renal transplant patients. In the present study the efficacy and safety of prophylactic rituximab is studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Recipients of first or second renal transplants\n* Recipients of kidneys from living or cadaveric donors\n* Single organ recipients (kidney only)\n* Patients providing written informed consent\n* Patients cooperative and able to complete all the assessment procedures\n\nExclusion Criteria:\n\n* Patients receiving other immunosuppressive therapy within the preceding 28 days\n* Recipients of HLA-identical sibling kidneys\n* Patients with flow-PRA \\>50% within 6 months prior to enrolment\n* Recent history of malignancy\n* Active infection\n* Pregnant or lactating females\n* Women of childbearing potential not willing to use reliable form of contraception'}, 'identificationModule': {'nctId': 'NCT00255593', 'briefTitle': 'Safety and Efficacy Study of Rituximab in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'A Prospective, Randomised, Placebo Controlled, Multicenter Study of the Efficacy and Safety of Rituximab as Induction Therapy Together With Tacrolimus, Mycophenolate Mofetil and Steroids for Patients Undergoing Renal Transplantation', 'orgStudyIdInfo': {'id': 'Eudra CT: 2005-001231-29'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Transplantation Surgery, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Gunnar E Tydén, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}}}}