Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
Study NCT ID:
NCT00820469
Status:
COMPLETED
Last Update Posted:
2017-05-12
First Post:
2009-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the total AUC levels between 2 arms : patients treated by rituximab alone or patients treated by rituximab and plasma exchange', 'timeFrame': 'Determination on the overall plasma concentration profile between the start of infusion and three months after the start of infusion'}], 'secondaryOutcomes': [{'measure': 'Determination of amount rituximab eliminated during a plasma exchange', 'timeFrame': 'At each plasma exchange'}, {'measure': 'Evaluation of the efficacy of the treatment by CD19+B Cell count', 'timeFrame': '15 dyas, 1, 2, 3, 6 and 9 months after rituximab infusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rituximab', 'Plasma exchange', 'Autoimmune diseases'], 'conditions': ['Renal Transplant', 'Autoimmune Diseases']}, 'referencesModule': {'references': [{'pmid': '23432476', 'type': 'RESULT', 'citation': 'Puisset F, White-Koning M, Kamar N, Huart A, Haberer F, Blasco H, Le Guellec C, Lafont T, Grand A, Rostaing L, Chatelut E, Pourrat J. Population pharmacokinetics of rituximab with or without plasmapheresis in kidney patients with antibody-mediated disease. Br J Clin Pharmacol. 2013 Nov;76(5):734-40. doi: 10.1111/bcp.12098.'}]}, 'descriptionModule': {'briefSummary': 'Rituximab (a monoclonal antibody raised against CD20) is used to treat various immune disorders. In some cases such as treatment of humoral acute rejection of renal transplant, thrombotic thrombocytopenic purpura, vasculitis or cryoglobulinemia, rituximab is often associated with plasma exchange. The pharmacokinetic of the rituximab can be affected by plasma exchange but the knowledge is poor in this matter.\n\nThe aim of the study is to explore the influence of plasma exchange on the pharmacokinetic of rituximab.\n\nThe results of this study should conclude if plasma exchange leads to a significant decrease of plasma concentration of rituximab or not, and if the decreased of the concentration is associated with a decrease in efficacy.', 'detailedDescription': 'Twenty patients will be enrolled: ten patients treated by rituximab and ten patients treated by rituximab and plasma exchange. The plasma concentration of rituximab and the efficacy of the treatment will be compared between the two groups of patients.\n\nThe enrollment in the study will not change the treatment of patients except for blood sampling.\n\nEach patient will undergo fifteen blood samples between the start of infusion of rituximab and three months after the start of infusion. For the patients who will undergo plasma exchange, three additional blood samples will be performed at each plasma exchange (at the start, at the end and one day after the plasma exchange) and a sample of the plasma exchanged will be keep.\n\nThe plasma concentration of rituximab will be determined by ELISA method (Enzyme Linked ImmunoSorbent Assay) The pharmacokinetic analyse will consist in the determination of the Area Under the Concentration Curve (AUC) by a non compartmental approach.\n\nThe AUC levels will be compared (using the t Student test) between the two populations of patients (patients treated by rituximab, versus patients treated by rituximab and plasma exchange) The efficacy of the treatment will be evaluated by the CD19+ B Cell count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who should be treated by rituximab for various autoimmune diseases or humoral acute rejection of renal transplant\n* Patient older than 18 years old\n* Patient who have signed the written informed consent form\n\nExclusion Criteria:\n\n* Patient presenting a contra indication to rituximab (hypersensitivity, active infection, severe cardiac failure (NYHA class IV))\n* Blood sampling impossibility\n* Pregnant or breasting women'}, 'identificationModule': {'nctId': 'NCT00820469', 'acronym': 'PK-rituximab', 'briefTitle': 'Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Influence of Plasma Exchange Therapy on the Pharmacokinetics of Rituximab in Patients Treated for Autoimmune Disorders.', 'orgStudyIdInfo': {'id': '07 140 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients treated by rituximab', 'interventionNames': ['Drug: Rituximab 375']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Patients treated by rituximab and plasma exchange', 'interventionNames': ['Drug: rituximab 1000']}], 'interventions': [{'name': 'Rituximab 375', 'type': 'DRUG', 'description': 'rituximab 375 mg/m2 IV weekly, during 4 weeks', 'armGroupLabels': ['1']}, {'name': 'rituximab 1000', 'type': 'DRUG', 'description': 'rituximab 1000 mg IV, two infusions on day 1 and day 15', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jacques Pourrat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}