Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 11:51 AM
Study NCT ID:
NCT01068067
Status:
UNKNOWN
Last Update Posted:
2010-07-28
First Post:
2010-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2010-07-26', 'studyFirstSubmitDate': '2010-02-11', 'studyFirstSubmitQcDate': '2010-02-11', 'lastUpdatePostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C0 of tacrolimus after the initial dose, the percentage of out-of-range C0 after initial dose, the number of dose adjustments made to achieve therapeutic range (5-10 ng/ml) and the dose requirement to reach therapeutic range', 'timeFrame': 'not less than three days after initial dose and not more than one month'}], 'secondaryOutcomes': [{'measure': 'acute rejection rate within two weeks after transplantation', 'timeFrame': 'within two weeks after transplantation'}, {'measure': 'serum creatinine at fourteen days after transplantation', 'timeFrame': 'fourteen days after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://ghr.nlm.nih.gov/handbook', 'label': 'Help Me Understand Genetics'}, {'url': 'http://ghr.nlm.nih.gov/glossary=cytochromep450', 'label': 'Cytochrome P450'}, {'url': 'http://www.nlm.nih.gov/medlineplus/druginfo/meds/a601117.html', 'label': 'Tacrolimus'}, {'url': 'http://en.wikipedia.org/wiki/Kidney_transplantation', 'label': 'Kidney (Renal) transplantation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University\n2. Wish to participate in the study\n3. Informed consent for the trial\n\nExclusion Criteria:\n\n1. Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus\n2. Patients with ABO-incompatible renal transplantation\n3. Panel reactive antibody (PRA) levels greater than 30% before transplantation\n4. Underwent combined organ transplantations\n5. Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used\n6. Allergic history to study medicines\n7. During pregnancy or plan to get pregnant during the study period'}, 'identificationModule': {'nctId': 'NCT01068067', 'briefTitle': 'Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Chinese Renal Transplant Recipients: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'TAC+WUZHI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pharmacogenetics plus SchE guided dosing', 'interventionNames': ['Other: drug (tacrolimus and SchE) and genetics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard dosing', 'interventionNames': ['Drug: tacrolimus']}], 'interventions': [{'name': 'drug (tacrolimus and SchE) and genetics', 'type': 'OTHER', 'description': 'Patients were genotyped for the polymorphisms that can influence tacrolimus pharmacokinetics before transplantation. After transplantation, initial tacrolimus dosage was based on an algorism guided by pharmacogenetics and SchE.', 'armGroupLabels': ['pharmacogenetics plus SchE guided dosing']}, {'name': 'tacrolimus', 'type': 'DRUG', 'description': 'After transplantation, patients received standard initial dose of tacrolimus (0.050-0.075 mg/kg).', 'armGroupLabels': ['standard dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Huang, PhD', 'role': 'CONTACT', 'email': 'huangmin@mail.sysu.edu.cn', 'phone': '86-20-39943011'}, {'name': 'Jia-Li Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xue-Ding Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang-Xi Wang, MD', 'role': 'CONTACT', 'email': 'wcx6363@163.com', 'phone': '86-20-87755766', 'phoneExt': '813'}, {'name': 'Qian Fu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Long-Shan Liu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Min Huang, PhD', 'role': 'CONTACT', 'email': 'huangmin@mail.sysu.edu.cn', 'phone': '86-20-39943011'}], 'overallOfficials': [{'name': 'Min Huang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University'}, {'name': 'Chang-Xi Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kidney Transplant Department, Transplant Center, the First Affiliated Hospital of Sun Yat-sen University'}, {'name': 'Jia-Li Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University'}, {'name': 'Xue-Ding Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University'}, {'name': 'Si-Yang Chen, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesia Department, the First Affiliated Hospital of Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Min Huang', 'oldOrganization': 'School of Pharmaceutical Sciences, Sun Yat-sen University'}}}}