Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 10:02 PM
Study NCT ID:
NCT06577805
Status:
RECRUITING
Last Update Posted:
2024-09-03
First Post:
2024-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcomes of Living Donor Robotic Assisted Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2024-08-24', 'studyFirstSubmitQcDate': '2024-08-27', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The graft function of recipients', 'timeFrame': 'in the follow-up period，about six months to one year', 'description': 'the graft function of recipients per month after transplant surgery, assessed by the serum creatinine (umol/L) and estimated glomerular function rate (eGFR).'}], 'secondaryOutcomes': [{'measure': 'total operative time', 'timeFrame': 'about 150 minutes to 300 minutes', 'description': 'The time from the beginning of the procedure to the end of the procedure (minute)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robotic surgery'], 'conditions': ['Kidney Transplant; Complications', 'Renal Failure Chronic']}, 'referencesModule': {'references': [{'pmid': '40988626', 'type': 'DERIVED', 'citation': 'Tang Y, Zhang H, Yin S, Li Y, Zeng J, Lin T, Song T. The Early Outcomes of Robotic-Assisted Kidney Transplantation Using Grafts With Multiple Arteries From a High-Volume Center: A Retrospective Cohort Study. Clin Transplant. 2025 Oct;39(10):e70328. doi: 10.1111/ctr.70328.'}]}, 'descriptionModule': {'briefSummary': 'The technology for robot-assisted kidney transplantation (RAKT) has become increasingly advanced, with numerous studies demonstrating comparable outcomes between RAKT surgery and open surgery. This advancement is particularly noteworthy as it extends its suitability to transplant patients with obesity. It will be important to explore the results of robot-assisted kidney transplantation as compared with open surgery or within cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage 5 chronic kidney disease undergoing living robot-assisted kidney transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. living-donor kidney transplant recipients\n2. receiving standard triad immunosuppressive regimen\n\nExclusion Criteria:\n\n1. active infection\n2. multi-organ transplantation\n3. malignancy history in the donor and recipient\n4. human immunodeficiency virus infection'}, 'identificationModule': {'nctId': 'NCT06577805', 'acronym': 'RAKT', 'briefTitle': 'The Outcomes of Living Donor Robotic Assisted Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Retrospective Cohort Study of Prospectively Collect the Outcomes of Recipients After Robot-assisted Kidney Transplantation', 'orgStudyIdInfo': {'id': 'WestChina-RAKT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'grafts with a single artery (GSA)', 'description': 'recipients of grafts with a single artery undergoing living donor robotic-assisted kidney transplantation'}, {'label': 'grafts with multiple single arteries (GMA)', 'description': 'recipients of grafts with multiple renal arteries undergoing living donor robotic-assisted kidney transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'phone': '28 85582944', 'phoneExt': '+86'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Tao Lin, M.D.', 'role': 'CONTACT', 'email': 'kidney5@163.com', 'phone': '028 85582944', 'phoneExt': '+86'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Tao Lin', 'investigatorFullName': 'Tao Lin', 'investigatorAffiliation': 'West China Hospital'}}}}