Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-01-02 @ 6:11 AM
Study NCT ID:
NCT01468493
Status:
UNKNOWN
Last Update Posted:
2017-04-24
First Post:
2011-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2011-10-29', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum suPAR level when proteinuria reduction >=50% or complete remission', 'timeFrame': '6 months after steriod alone or CsA plus steriod treatment', 'description': 'serum suPAR level when proteinuria reduction of \\>=50% or complete remission occurs within \\<=6 months of steroid alone or CsA plus steroid treatment'}], 'secondaryOutcomes': [{'measure': 'serum suPAR level after 6 months of steroid or CsA treatment without remission', 'timeFrame': '6 months after steroid alone or CsA plus steroid treatment', 'description': 'serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['FSGS', 'suPAR'], 'conditions': ['FSGS']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether the improved responsiveness to treatment achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be explained by CsA's inhibitory action on the circulating suPAR expression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1)the patients with steroid-sensitive FSGS;2)the cyclosporine A-treated patients with steroid-dependent and steroid-resistant FSGS;3)the healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at entry is between 14 and 70 years\n* biopsy-proven primary FSGS\n* proteinuria \\>=3 g/day\n* without corticosteroids or CsA treatment before entry\n\nExclusion Criteria:\n\n* Chronic Inflammatory Diseases\n* malignant tumor\n* diabetes mellitus\n* contraindications for the treatment of corticosteroids or CsA treatment\n* untolerate to or unwilling to accept corticosteroids or CsA treatment'}, 'identificationModule': {'nctId': 'NCT01468493', 'acronym': 'SuparSDRF', 'briefTitle': 'A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Prospective Controlled Follow-up of Serum Soluble Urokinase Receptor in the Cyclosporine A-treated Patients With Steroid-dependent and Steroid-resistant Focal Segmental Glomerulosclerosis', 'orgStudyIdInfo': {'id': 'GGH-1-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'steroid-sensitive FSGS'}, {'label': 'steroid-dependent and resistant FSGS'}, {'label': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Shi, MD,PhD', 'role': 'CONTACT', 'email': 'weishi_gz@126.com', 'phone': '86-20-8385-0849'}, {'name': 'Bin Zhang, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruizhao Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nephrology Dept.,Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wei Shi, MD,PhD', 'role': 'CONTACT', 'email': 'weishi_gz@126.com', 'phone': '86-20-8385-0849'}], 'overallOfficials': [{'name': 'Wei Shi, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nephrology Dept.,Guangdong General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of renal division of Guangdong General Hospital', 'investigatorFullName': 'Wei Shi', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}