Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-04-01 @ 11:17 AM
Study NCT ID:
NCT02392312
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2015-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2015-03-13', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse event', 'timeFrame': 'up to 3 months post-transplantation'}], 'secondaryOutcomes': [{'measure': 'Clinical diagnosis of acute rejection', 'timeFrame': 'up to 3 months post-transplantation'}, {'measure': 'Renal function: serum creatinine', 'timeFrame': 'at month 1 and month 3'}, {'measure': 'Incidence of delayed graft function (DGF)', 'timeFrame': 'up to 3 months post-transplantation'}, {'measure': 'Patient and graft survival', 'timeFrame': 'up to 3 months post-transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney transplant', 'ATG-F'], 'conditions': ['Kidney Transplant Recipients']}, 'descriptionModule': {'briefSummary': 'A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Governmental Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ATG-F administration to prophylaxis rejection in kidney transplantation recipient.\n* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients.).\n* Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.\n* Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.\n* Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.\n* Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.\n* Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.'}, 'identificationModule': {'nctId': 'NCT02392312', 'briefTitle': 'Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study', 'orgStudyIdInfo': {'id': 'ATG-MA-ACN001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ATF-Fresenius S', 'description': 'intravenous', 'interventionNames': ['Drug: ATF-Fresenius S']}], 'interventions': [{'name': 'ATF-Fresenius S', 'type': 'DRUG', 'description': 'intravenous', 'armGroupLabels': ['ATF-Fresenius S']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baotou', 'country': 'China', 'facility': 'Site: CN00004', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Site: CN00011', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Site: CN00012', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Site: CN00013', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'Site: CN00016', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Chengdu', 'country': 'China', 'facility': 'Site: CN00002', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Site: CN00003', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'country': 'China', 'facility': 'Site: CN00018', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Site: CN00023', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Haikou', 'country': 'China', 'facility': 'Site: CN00021', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Haikou', 'country': 'China', 'facility': 'Site: CN00022', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Site: CN00019', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Site: CN00020', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Site: CN00006', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Site: CN00017', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Kunming', 'country': 'China', 'facility': 'Site: CN00028', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Nanchang', 'country': 'China', 'facility': 'Site: CN00030', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Qingdao', 'country': 'China', 'facility': 'Site: CN00015', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shiyan', 'country': 'China', 'facility': 'Site: CN00010', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'city': 'Taiyuan', 'country': 'China', 'facility': 'Site: CN00014', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Site: CN00005', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'country': 'China', 'facility': 'Site: CN00031', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': "Xi'an", 'country': 'China', 'facility': 'Site: CN00001', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Yantai', 'country': 'China', 'facility': 'Site: CN00033', 'geoPoint': {'lat': 37.47649, 'lon': 121.44081}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'Site: CN00007', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma China, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma China, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}