Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 9:32 AM
Study NCT ID:
NCT01334333
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2011-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2011-04-11', 'studyFirstSubmitQcDate': '2011-04-12', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'electronic monitor of medication taking', 'timeFrame': '4 months', 'description': 'electronic bottle tops will be used to monitor medication adherence using MEMS (medication event monitoring system) Caps technology for a period of 4 months.'}], 'secondaryOutcomes': [{'measure': 'blood levels of medication', 'timeFrame': '4 months', 'description': 'blood levels of tacrolimus will be monitored throughout the study.'}, {'measure': 'self-reported medication adherence', 'timeFrame': '4 months', 'description': 'self-report medication adherence questionnaires will also be used to assess medication adherence.'}, {'measure': 'pharmacy refill data', 'timeFrame': '4 months', 'description': 'pharmacy refill data from the hospital pharmacy where all participants receive their medications will also be examined to determine medication adherence.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney transplant', 'tacrolimus', 'medication adherence', 'depression', 'neuropsychological', 'cognition', 'Self-efficacy', 'everyday problem solving'], 'conditions': ['Renal Disease', 'Renal Transplant']}, 'referencesModule': {'references': [{'pmid': '36094829', 'type': 'DERIVED', 'citation': "Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2."}, {'pmid': '31452902', 'type': 'DERIVED', 'citation': 'Paterson TSE, Demian M, Shapiro RJ, Loken Thornton W. Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Aug 17;6:2054358119867993. doi: 10.1177/2054358119867993. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant.\n\nThe Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning \\[4\\]. The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration.\n\nThe current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients.\n\nThe proposed research has two primary aims to examine:\n\n1. To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.\n2. To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a minimum of one year post renal transplant with a successful kidney graft and stable renal function (estimated glomerular filtration rate \\[GFR (glomerular filtration rate)\\] above 25 ml/minute per 1.73 m2).\n* currently prescribed tacrolimus\n* able to swallow pills\n* a minimum of grade six education\n* fluent in the English language.\n\nExclusion Criteria:\n\n* refusal to or inability to give written informed consent.\n* any visual, hearing or other sensory/motor impairments which may interfere with the testing procedures.\n* have had a stroke determined to be of significant severity\n* have had a head injury determined to be of significant severity\n* have a current psychiatric diagnosis determined to be of significant severity\n* have the presence of an acute illness (e.g., metastatic cancer), neurological disease, and other major organ failure (e.g., end stage liver disease)'}, 'identificationModule': {'nctId': 'NCT01334333', 'briefTitle': 'Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study', 'orgStudyIdInfo': {'id': 'H11-00446'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prograf®', 'description': 'Prograf® is a twice daily formulation of tacrolimus', 'interventionNames': ['Drug: Tacrolimus - Prograf® twice daily formulation']}, {'type': 'EXPERIMENTAL', 'label': 'Advagraf®', 'description': 'Advagraf® is a once daily formulation of tacrolimus', 'interventionNames': ['Drug: Tacrolimus - Advagraf® once daily formulation']}], 'interventions': [{'name': 'Tacrolimus - Prograf® twice daily formulation', 'type': 'DRUG', 'otherNames': ['Prograf®'], 'description': 'twice daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant', 'armGroupLabels': ['Prograf®']}, {'name': 'Tacrolimus - Advagraf® once daily formulation', 'type': 'DRUG', 'otherNames': ['Advagraf®'], 'description': 'once daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant', 'armGroupLabels': ['Advagraf®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Solid Organ Transplant Clinic, Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'R. Jean Shapiro, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Wendy Loken Thornton, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simon Fraser University'}, {'name': 'Nilufar Partovi, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Theone SE Paterson, M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simon Fraser University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Simon Fraser University', 'class': 'OTHER'}, {'name': 'Astellas Pharma Canada, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}