Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06585293
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-29', 'size': 684361, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-30T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-09-02', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of an in-house LC-MS/MS method and L4L-Analyst quantitative software for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device.', 'timeFrame': '6 months', 'description': 'Validation of an in-house LC-MS/MS method for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device to UKAS standards, in accordance with ISO 15189, for routine clinical practice.'}], 'secondaryOutcomes': [{'measure': 'Questionnaire to assess whether the new sample collection method improves patient experience', 'timeFrame': '6 months', 'description': 'Patient satisfaction questionnaire using a 5-point likert scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunosuppression']}, 'referencesModule': {'references': [{'pmid': '32713180', 'type': 'BACKGROUND', 'citation': 'Marshall DJ, Kim JJ, Brand S, Bryne C, Keevil BG. Assessment of tacrolimus and creatinine concentration collected using Mitra microsampling devices. Ann Clin Biochem. 2020 Sep;57(5):389-396. doi: 10.1177/0004563220948886. Epub 2020 Aug 20.'}]}, 'descriptionModule': {'briefSummary': "Organ transplant rejection occurs when the immune system attacks the transplanted organ. To prevent rejection, transplant-patients are given immunosuppressant drugs which can suppress the immune system from attacking the transplanted organ. Patients who have had a kidney-transplant take immunosuppressant drugs such as tacrolimus, but the dosage must be closely monitored through regular blood tests to avoid complications like organ failure and kidney damage. The current practice at Nottingham University Hospitals NHS Trust is that kidney-transplant patients being monitored for tacrolimus have regular blood samples taken by venepuncture (vein), and the samples are sent to the laboratory to be measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS), a technique used in chemistry to identify and quantify substances in a sample. Patients will also often have their blood-creatinine measured to get an idea of kidney health. Visits to the GP/hospital for this type of blood collection can be disruptive to a patient's daily life and stretches resources of the NHS. An alternative blood sample collection process involves the use of a hand-held blood collecting device called a Mitra device, designed to allow patients to collect samples at home through a finger-prick and send them by post for analysis. This method is especially beneficial for those who find hospital visits challenging or venepuncture painful.\n\nThis study aims to develop an LC-MS/MS method for measurement of tacrolimus and creatinine, using finger-prick samples collected on the Mitra device. To do this, kidney-transplant patients who are having routine venepuncture to measure tacrolimus and creatinine will simultaneously have a finger-prick sample collected using the Mitra device. Both the venepuncture sample and finger-prick samples will be analysed using existing LC-MS/MS technology to determine tacrolimus and creatinine values. The LC-MS/MS analysis method for the finger-prick samples collected using the Mitra device will be optimised and then results obtained using this method will be compared to the results obtained from venepuncture-collected samples to ensure consistency of results. Agreement of results between the two analysis methods will confirm the suitability of LC-MS/MS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.\n\nExclusion Criteria:\n\n* No exclusion criteria'}, 'identificationModule': {'nctId': 'NCT06585293', 'briefTitle': 'Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': 'Developing an LC-MS/MS Method for Measurement of Tacrolimus and Creatinine Concentration From Finger-prick Blood Collected Using the Mitra Device', 'orgStudyIdInfo': {'id': '24PA006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mitra Microsampling Device', 'type': 'DEVICE', 'description': 'Microsampling tool for finger-prick blood collection'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Donna M Fullerton, PhD, FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}