Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-26 @ 5:53 AM
Study NCT ID:
NCT01758120
Status:
UNKNOWN
Last Update Posted:
2017-07-14
First Post:
2012-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-02-04', 'releaseDate': '2021-01-18'}], 'estimatedResultsFirstSubmitDate': '2021-01-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-25', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events', 'timeFrame': '1,3,6 ,12, 24 and 36 months or more after treatment', 'description': 'Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.'}], 'primaryOutcomes': [{'measure': 'the changes of kidney function or death', 'timeFrame': '3,6 ,12, 24 and 36 months or more after treatment', 'description': 'the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death'}], 'secondaryOutcomes': [{'measure': 'the changes of proteinuria', 'timeFrame': '3,6 ,12, 24 and 36 months or more after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgA nephropathy', 'Cyclophosphamide', 'prednisone'], 'conditions': ['IgA Nephropathy']}, 'descriptionModule': {'briefSummary': 'Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy-proven primary IgA nephropathy;\n* 18-70 years old;\n* elevated serum Creatinine and less than 3.0mg/dl;\n* with a written consent from participants to receive prednisone and/or cyclophosphamide\n\nExclusion Criteria:\n\n* diabetes;\n* contraindications for the treatment of prednisone and/or cyclophosphamide;\n* any treatment with steroids or immunosuppressive drugs prior to this study;\n* acute deterioration of renal function(including those of glomerular origin)'}, 'identificationModule': {'nctId': 'NCT01758120', 'acronym': 'TOPplus-IgAN', 'briefTitle': 'Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy', 'orgStudyIdInfo': {'id': 'GGH2012-36'}, 'secondaryIdInfos': [{'id': 'GGH2012-36', 'type': 'OTHER', 'domain': 'GGH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prednisone plus cyclophosphamide', 'description': 'prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\\*6months)', 'interventionNames': ['Drug: prednisone plus cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'prednisone alone', 'description': 'prednisone alone: prednisone(0.5mg/kg/day\\*6 months)', 'interventionNames': ['Drug: Prednisone alone']}], 'interventions': [{'name': 'prednisone plus cyclophosphamide', 'type': 'DRUG', 'description': '1. prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\\*6months);\n2. supportive care,including ACE-I or ARBs and blood pressure control', 'armGroupLabels': ['prednisone plus cyclophosphamide']}, {'name': 'Prednisone alone', 'type': 'DRUG', 'description': '1. prednisone alone: prednisone(0.5mg/kg/day\\*6 months);\n2. supportive care,including ACE-I or ARBs and blood pressure control', 'armGroupLabels': ['prednisone alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'wei shi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'Wei Shi', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-01-18', 'type': 'RELEASE'}, {'date': '2021-02-04', 'type': 'RESET'}], 'unpostedResponsibleParty': "Wei Shi, clinical professor, Guangdong Provincial People's Hospital"}}}}