Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT03465969
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2018-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of blood concentrations of tacrolimus', 'timeFrame': 'Day 1', 'description': 'Tacrolimus concentrations will be determined from the dried whole blood samples collected via finger prick into MITRA cartridge and in whole blood taken by venipuncture.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplantation', 'A Bioanalytical Method Cross-validation', 'Advagraf', 'Liver transplantation'], 'conditions': ['Kidney Transplantation', 'Liver Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.', 'detailedDescription': 'This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject will be a recipient of either a liver or kidney transplant and on a stable dose of commercial Advagraf minimum of 3 months.\n* Subjects will be with clinically stable graft function for at least 3 months.\n\nExclusion Criteria:\n\n* Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT03465969', 'acronym': 'MITRA', 'briefTitle': 'A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Bioanalytical Method Cross-validation Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients', 'orgStudyIdInfo': {'id': '506-MA-3189'}, 'secondaryIdInfos': [{'id': '2017-004121-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Liver or kidney transplant participants of Advagraf', 'description': "Transplant participants will provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose of participant's usual oral dose of commercial Advagraf and at approximately 1 and 3 hours post-dose.", 'interventionNames': ['Drug: tacrolimus']}], 'interventions': [{'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['Advagraf'], 'description': 'oral', 'armGroupLabels': ['Liver or kidney transplant participants of Advagraf']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Site FR33002', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Site FR33001', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Site UK44002', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Site UK44001', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Clinical Research Physician', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}