Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT03708094
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2018-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis Study of Renal Transplantation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal graft survival rate', 'timeFrame': '3 years after renal transplantation', 'description': 'The number of survival renal transplant graft in the 3 year observation period accounted for the percentage of the total cases studied.'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute rejection', 'timeFrame': '3 years after renal transplantation', 'description': 'The number of acute rejection after transplantation during the 3 year observation period accounted for the percentage of the total cases studied.'}, {'measure': 'Recurrence rate of primary disease', 'timeFrame': '3 years after renal transplantation', 'description': 'The number of patient with primary disease recurrence during the 3 year observation period accounted for the percentage of the total cases studied.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prognosis', 'pathogenic gene', 'decision tree study'], 'conditions': ['Kidney Failure']}, 'descriptionModule': {'briefSummary': 'Kidney transplantation is the worldwide recognized best renal replacement treatment for children with end-stage renal disease. Successful kidney transplantation can not only alleviate uremia symptoms, improve survival and quality of life, but also achieve optimal growth and cognitive development in children. Clarifying the cause of end-stage renal disease before transplantation is of vital importance to the comprehensive assessment and follow-up of the extra renal organs, reducing the risk of recurrence of the primary disease, the choice of the timing and the mode of transplantation, the scheme of immunosuppressive agents, as well as providing accurate genetic counseling for families. Timely molecular diagnosis and correct data analysis play a positive role in promoting the etiological diagnosis of uremic children before renal transplantation. We hypothesized that identifying the molecular diagnosis can improve prognosis of kidney transplantation. 300 cases of end-stage renal disease children were included and whole exome sequencing are performed to identify the molecular diagnosis. The cohort was divided into 2 groups according to whether the molecular diagnosis was clear. Clinical information before and after renal transplantation of each group are collected, and the decision tree analysis model and logistic regression model are used to study the effect of clear molecular diagnosis on the 3 year survival rate of renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 300 continuous renal transplant cases from multiple centers included in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Donors and recipients who accepted kidney transplantation at centers included in this study\n\nExclusion Criteria:\n\n* Older than 18 years old.\n* There are severe systemic diseases and/or local and/or spiritual system diseases.\n* There are systemic acute or chronic infections, infectious diseases.\n* The donated organ dysfunction, or other causes that are damage to donors and recipients.'}, 'identificationModule': {'nctId': 'NCT03708094', 'briefTitle': 'Prognosis Study of Renal Transplantation in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children', 'orgStudyIdInfo': {'id': 'TxGene 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'molecular diagnosis confirmed', 'description': 'Whole exome sequencing is applied to children and the molecular diagnosis was identified before renal transplantation.', 'interventionNames': ['Diagnostic Test: molecular diagnosis']}, {'label': 'molecular diagnosis unconfirmed', 'description': 'Whole exome sequencing is applied to children and the molecular diagnosis was not identified before renal transplantation.'}], 'interventions': [{'name': 'molecular diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': 'whole exome sequencing and data analysis to elucidating molecular diagnosis', 'armGroupLabels': ['molecular diagnosis confirmed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Children's hospital of Fudan university", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Hong Xu, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': "Boston Children's Hospital", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hong Xu，MD.PhD', 'investigatorAffiliation': "Children's Hospital of Fudan University"}}}}