Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05707520
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2023-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Benefit of MPA in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-28', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complex endpoint', 'timeFrame': '60 months after liver transplantation', 'description': 'Graft loss or reoccurrence of HCC, or neoplasm, or death'}], 'secondaryOutcomes': [{'measure': 'Late onset acute rejection', 'timeFrame': '60 months after liver transplantation', 'description': 'rejection diagnosed by liver test, pathologic diagnosis by biopsy'}, {'measure': 'Incidence of AKI or CKD', 'timeFrame': '60 months after liver transplantation', 'description': 'AKI/CKD diagnosed according to KDIGO 2012 AKI and CKD diagnosis criteria'}, {'measure': 'Adverse events', 'timeFrame': '60 months after liver transplantation', 'description': 'Incidence of leukopenia/neutropenia, incidence of viral infections, incidence of new tumors (non-liver cancer).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enteric-coated mycophenolate', 'adverse reaction', 'liver transplantation', 'transplant rejection'], 'conditions': ['Liver Transplant Rejection', 'Immunosuppressant Adverse Reaction']}, 'descriptionModule': {'briefSummary': "MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Long-term survived liver transplant recipients in 13 hospitals in China', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021;\n* Recipient's survival timeā„ 1 year;\n* Age 18\\~65 years old;\n* Patients with complete data and no loss to follow-up.\n\nExclusion Criteria:\n\n* use of other types of anti-metabolic immunosuppressants;\n* Second liver transplantation for various reasons within 1 year after the first transplantation;\n* Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors."}, 'identificationModule': {'nctId': 'NCT05707520', 'briefTitle': 'Long-term Benefit of MPA in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation', 'orgStudyIdInfo': {'id': '[2022]02-146-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MPA', 'description': 'Immunosuppressant with enteric-coated mycophenolate sodium', 'interventionNames': ['Drug: enteric-coated mycophenolate (MPAs)']}, {'label': 'None MPA', 'description': 'Immunosuppressant without enteric-coated mycophenolate sodium', 'interventionNames': ['Drug: None MPA']}], 'interventions': [{'name': 'enteric-coated mycophenolate (MPAs)', 'type': 'DRUG', 'description': 'Immunosuppression protocol with enteric-coated mycophenolate sodium', 'armGroupLabels': ['MPA']}, {'name': 'None MPA', 'type': 'DRUG', 'description': 'Immunosuppression protocol without enteric-coated mycophenolate sodium', 'armGroupLabels': ['None MPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Yang, PHD', 'role': 'CONTACT', 'email': 'yysysu@163.com'}, {'name': 'Yingcai Zhang', 'role': 'CONTACT', 'email': '76207884@qq.com'}, {'name': 'Yang Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huimin Yi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Haijin Lv, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hui Zhao, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Third Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yang Yang, PhD', 'role': 'CONTACT', 'email': 'yysysu@163.com', 'phone': '+8618922102666'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'individual participant data will be shared on ResMan, after completion and the consent from investigators and IRB'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shulan (Hangzhou) Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'The Third Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of third Affiliated Hospital, Sun Yat-Sen University', 'investigatorFullName': 'Yang Yang', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}