Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-03-30 @ 7:34 AM
Study NCT ID:
NCT02077556
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2014-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2014-03-02', 'studyFirstSubmitQcDate': '2014-03-02', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profiles', 'timeFrame': 'Post-operation day 8-10', 'description': 'Pharmacokinetic parameters include the maximum concentration, trough concentration, area under the whole-blood concentration-time curve between 0 and 12 hours, time to maximum concentration, volume of distribution at steady state, and clearance at steady state.'}], 'secondaryOutcomes': [{'measure': 'Acute rejection', 'timeFrame': 'Within the first 2 weeks post-transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tacrolimus, everolimus, pharmacokinetics, drug interaction'], 'conditions': ['Drug Interaction Potentiation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.', 'detailedDescription': 'Multidrug immunosuppression regimens have synergistic effects which allow the use of lower doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs: cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4 and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.\n\nIt is remained to be evaluated whether the pharmacokinetics or clinical efficacy of tacrolimus will be affected when the regimens contain everolimus in clinical practice and the effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs was also assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* De novo kidney transplants\n* 20 - 65 years old\n* aspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range\n\nExclusion criteria:\n\n* Pregnancy\n* Tuberculosis\n* Hepatitis B or C carrier status\n* Human immunodeficiency virus-positive status\n* Retransplantation or multiorgan transplantation\n* History of rheumatoid arthritis\n* Use of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity'}, 'identificationModule': {'nctId': 'NCT02077556', 'briefTitle': 'Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs', 'orgStudyIdInfo': {'id': '201312011MINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus', 'description': 'Everolimus/Tacrolimus/Methylprednisolone \\& Prednisolone', 'interventionNames': ['Drug: Everolimus', 'Drug: Tacrolimus', 'Drug: Methylprednisolone', 'Drug: Prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mycophenolate mofetil', 'description': 'Mycophenolate mofetil/Tacrolimus/ Methylprednisolone \\& Prednisolone', 'interventionNames': ['Drug: Mycophenolate mofetil', 'Drug: Tacrolimus', 'Drug: Methylprednisolone', 'Drug: Prednisolone']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certican'], 'description': 'Everolimus: 1 mg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 3-8 ng/mL', 'armGroupLabels': ['Everolimus']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': 'Mycophenolate mofetil: 10-15 mg/kg orally every 12 hours from post-operation day 1 (decrease 50% dose if white blood cell \\< 4000/mcL)', 'armGroupLabels': ['Mycophenolate mofetil']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf'], 'description': 'Tacrolimus: 0.05-0.075 mg/kg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 8-12 ng/mL', 'armGroupLabels': ['Everolimus', 'Mycophenolate mofetil']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solu-Medrol'], 'description': 'Methylprednisolone: 50 mg iv every 6 hours on post-operation day 1, 40 mg iv every 6 hours on post-operation day 2, 30 mg iv every 6 hours on post-operation day 3, 20 mg iv every 6 hours on post-operation day 4, 20 mg iv every 8 hours on post-operation day 5, 20 mg iv every 12 hours on post-operation day 6, 20 mg iv on post-operation day 7', 'armGroupLabels': ['Everolimus', 'Mycophenolate mofetil']}, {'name': 'Prednisolone', 'type': 'DRUG', 'otherNames': ['Predonine'], 'description': 'Prednisolone: 20 mg orally once a day from post-operation day 8 to post-operation week 4, then titrated gradually', 'armGroupLabels': ['Everolimus', 'Mycophenolate mofetil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Meng-Kun Tsai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}