Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 1:02 AM
Study NCT ID:
NCT06020534
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Aortoiliac Stenosis in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'y.fang.1@erasmusmc.nl', 'phone': '+31 645680154', 'title': 'Drs. Yitian Fang', 'organization': 'Erasmus Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "Firstly, there is a guarantee for selection bias in patients with the most severe aortoiliac stenosis, as these patients might be rejected for kidney transplantation and would not be included in the study. Secondly, the study's single-center design could introduce institutional-speciļ¬c practices that may not be universally applicable. Lastly, details of stenosis proximal or distal to the transplanted kidney were unknown."}}, 'adverseEventsModule': {'timeFrame': 'The time frame for adverse event is from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'eventGroups': [{'id': 'EG000', 'title': 'No-stenosis Group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.', 'otherNumAtRisk': 524, 'deathsNumAtRisk': 524, 'otherNumAffected': 0, 'seriousNumAtRisk': 524, 'deathsNumAffected': 202, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TASC A/B Stenosis', 'description': 'Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.', 'otherNumAtRisk': 96, 'deathsNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'deathsNumAffected': 48, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TASC C/D Stenosis', 'description': 'Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 29, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No-stenosis Group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG001', 'title': 'TASC A/B Stenosis', 'description': 'Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG002', 'title': 'TASC C/D Stenosis', 'description': 'Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.'}], 'classes': [{'categories': [{'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Patient survival was calculated based on all-cause death from the date of kidney transplantation till the end of follow-up (January, 2023), assessed up to 10 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death-censored Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No-stenosis Group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG001', 'title': 'TASC A/B Stenosis Group', 'description': 'Patients who had TASC A/B aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG002', 'title': 'TASC C/D Stenosis Group', 'description': 'Patients who had TASC C/D aortoiliac stenosis before kidney transplantation.'}], 'classes': [{'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Death-censored graft survival was calculated based on death-censored graft failure, from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Graft Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'No-stenosis Group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG001', 'title': 'TASC A/B Stenosis Group', 'description': 'Patients who had TASC A/B aortoiliac stenosis before kidney transplantation.'}, {'id': 'OG002', 'title': 'TASC C/D Stenosis Group', 'description': 'Patients who had TASC C/D aortoiliac stenosis before kidney transplantation.'}], 'classes': [{'title': '1 year posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '476', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '59'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '61'}, {'value': '46', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '54'}]}]}, {'title': '2 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '59'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '37', 'upperLimit': '63'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '52'}]}]}, {'title': '3 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '61'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '33', 'upperLimit': '61'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '35', 'upperLimit': '45'}]}]}, {'title': '4 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '62'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '59'}, {'value': '42', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '50'}]}]}, {'title': '5 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '61'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '59'}, {'value': '38', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '48'}]}]}, {'title': '6 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '62'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '60'}, {'value': '46', 'groupId': 'OG002', 'lowerLimit': '31', 'upperLimit': '49'}]}]}, {'title': '7 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '65'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '56'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '47'}]}]}, {'title': '8 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '58'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '44', 'upperLimit': '57'}]}]}, {'title': '9 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '62'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '55'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '49', 'upperLimit': '58'}]}]}, {'title': '10 years posttransplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '61'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '43'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '40', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at every post transplant year up to 10 years.', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The discrepancy in the number of participants analyzed in one or more rows compared to the overall number of participants was due to attrition from graft failure or patient death over time.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No-stenosis Group', 'description': 'After PSM, patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'id': 'FG001', 'title': 'TASC A/B Stenosis', 'description': 'Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.'}, {'id': 'FG002', 'title': 'TASC C/D Stenosis', 'description': 'Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '524'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '524'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'We initially identified all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020. The exclusion criteria were age less than 18 years when transplanted, combined organ transplantation, or no follow-up data.', 'preAssignmentDetails': 'We initially identified 2127 participants. Thirty-six patients were excluded according to the exclusion criteria. In the remaining participants, propensity score matching was performed in a nearest neighbor-matching approach with a maximum caliper of 0.1 in a 1 : 4 ratio to match the baseline characteristics of participants with and without aortoiliac stenosis. The matching parameters included age at transplant, dialysis mode, retransplant, donor type, comorbidities, and smoking status.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'No-stenosis Group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'id': 'BG001', 'title': 'TASC A/B Stenosis Group', 'description': 'Patients who had TASC A/B aortoiliac stenosis before kidney transplantation.'}, {'id': 'BG002', 'title': 'TASC C/D Stenosis Group', 'description': 'Patients who had TASC C/D aortoiliac stenosis before kidney transplantation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '71'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '70'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '59', 'upperLimit': '69'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '60', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '442', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '31'}, {'value': '27', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '32'}, {'value': '28', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '28', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Type of Dialysis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Pre-emptive', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '149', 'groupId': 'BG003'}]}, {'title': 'Hemodialysis', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '371', 'groupId': 'BG003'}]}, {'title': 'Peritoneal Dialysis', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Combined Modality', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Dialysis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '36'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '37'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '38'}, {'value': '22', 'groupId': 'BG003', 'lowerLimit': '12', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Retransplant', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Donor Type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Living Donor', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '360', 'groupId': 'BG003'}]}, {'title': 'DBD', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}, {'title': 'DCD', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '655', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never Smoker', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '188', 'groupId': 'BG003'}]}, {'title': 'Former Smoker', 'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '326', 'groupId': 'BG003'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Propensity score matching was performed in a nearest neighbor-matching approach with a maximum caliper of 0.1 in a 1 : 4 ratio to match patients in the stenosis group with individuals from the no-stenosis group who shared similar characteristics. The matching parameters included age, dialysis mode, retransplant, donor type, comorbidities, and smoking status.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-30', 'size': 892410, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T05:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2023-08-24', 'resultsFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Survival', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Patient survival was calculated based on all-cause death from the date of kidney transplantation till the end of follow-up (January, 2023), assessed up to 10 years.'}], 'secondaryOutcomes': [{'measure': 'Death-censored Graft Survival', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Death-censored graft survival was calculated based on death-censored graft failure, from the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.'}, {'measure': 'Graft Function', 'timeFrame': 'From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.', 'description': 'Estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at every post transplant year up to 10 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortoiliac arterial stenosis', 'peripheral arterial disease', 'kidney transplantation', 'outcomes'], 'conditions': ['Aorto-Iliac Arterial Stenosis', 'Peripheral Arterial Disease', 'Kidney Transplant Failure']}, 'referencesModule': {'references': [{'pmid': '38016127', 'type': 'DERIVED', 'citation': 'Fang Y, Hamm JJM, den Hartog FPJ, Kimenai HJAN, de Bruin RWF, Minnee RC. Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study. Int J Surg. 2024 Feb 1;110(2):992-999. doi: 10.1097/JS9.0000000000000926.'}]}, 'descriptionModule': {'briefSummary': 'The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.', 'detailedDescription': 'Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD). Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is considered as relative contra-indication for kidney transplantation. There are several reasons for concern, such as the complexity of the vascular anastomosis and inferior life expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would benefit from kidney transplantation.\n\nThis study aimed to supplement current literature on the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis. To achieve this, all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020 were enrolled, and propensity score matching was used to minimize confounding factors. Additionally, long-term graft function was investigated to evaluate the impact of stenosis on graft function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020\n\nExclusion Criteria:\n\n* Patients who were under 18 years at transplantation\n* Patients who underwent combined organ transplantation\n* Patients who had no follow-up'}, 'identificationModule': {'nctId': 'NCT06020534', 'acronym': 'TASC', 'briefTitle': 'Aortoiliac Stenosis in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis', 'orgStudyIdInfo': {'id': 'KT TASC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No-stenosis group', 'description': 'Patients who had no pre-existing aortoiliac stenosis before kidney transplantation.'}, {'label': 'TASC A/B stenosis', 'description': 'Patients who had TASC A or B aortoiliac stenosis before kidney transplantation.'}, {'label': 'TASC C/D stenosis', 'description': 'Patients who had TASC C or D aortoiliac stenosis before kidney transplantation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Yitian Fang', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Yitian Fang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support this study are not publicly available due to reasons of sensitivity and are available from the principal investigator upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yitian Fang, MD', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}