Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-01 @ 1:29 PM
Study NCT ID:
NCT01052259
Status:
TERMINATED
Last Update Posted:
2014-01-08
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C037258', 'term': 'gusperimus'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Insufficient patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histopathological findings by Banff criteria', 'timeFrame': '6 month after treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Renal function, proteinuria, graft survival, anti-HLA antibody, adverse events, serious adverse events (SAE)', 'timeFrame': '6 and 12 months after treatment initiation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic rejection', 'Kidney', 'Transplantation', 'Immunosuppressive'], 'conditions': ['Chronic Rejection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to examine the efficacy and safety of cycling treatment of deoxyspergualin in renal transplant patients with biopsy-proven chronic rejection.', 'detailedDescription': 'The primary aim of this study is to investigate the efficacy of deoxyspergualin after the completion of 6 cycles treatment. The efficacy valuables are histological findings in renal grafts, renal function, proteinuria, graft survival, anti-HLA antibody. The safety data are also evaluated in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic rejection defined by Banff 2007 criteria\n\nExclusion Criteria:\n\n* Patients who have recurrent renal diseases and virus-associated renal diseases\n* Patients who have initial WBC \\< 4,000, neutrophil \\< 1,000 , platelet \\< 50,000 or Hb \\< 8g\n* Patients who have acute or chronic infection'}, 'identificationModule': {'nctId': 'NCT01052259', 'briefTitle': 'Efficacy and Safety of Deoxyspergualin in Renal Transplant Patient With Chronic Rejection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nippon Kayaku Co., Ltd.'}, 'officialTitle': 'Pilot Study of Cycling Treatment of Deoxyspergualin in Biopsy-proven Chronic Rejection of Kidney Transplantation', 'orgStudyIdInfo': {'id': 'SPCR2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deoxyspergualin, Treatment,', 'interventionNames': ['Drug: Deoxyspergualin']}], 'interventions': [{'name': 'Deoxyspergualin', 'type': 'DRUG', 'otherNames': ['Spanidin, gusperimus hydrochloride'], 'description': '100mg/vial as active substance; Deoxyspergualin at 3-5 mg/kg/day by 1-3 iv infusion will be given once a day for 5 to 7 days each cycle every month; Total cycle treatment will be 6.', 'armGroupLabels': ['Deoxyspergualin, Treatment,']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010-8543', 'city': 'Akita', 'state': 'Akita', 'country': 'Japan', 'facility': 'Akita University School of Medicine', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Graduate School of Medicine Sciences, Kyushu University', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '501-1194', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Gifu University Graduate School of Medicine', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '060-8604', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo City General Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Graduate School of Medicine', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '335-0023', 'city': 'Toda', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Toda Central General Hospital', 'geoPoint': {'lat': 35.81447, 'lon': 139.66018}}, {'zip': '143-8541', 'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Graduate School of Medicine', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '162-8666', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University"}], 'overallOfficials': [{'name': 'Hiroshi Harada, Chief', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sapporo City General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nippon Kayaku Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}