Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03475602
Status:
TERMINATED
Last Update Posted:
2020-06-18
First Post:
2018-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Our center had adopted a new detection method for anti-PLA2R antibodies in all membranous nephropathy patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission', 'timeFrame': 'after treatment for 6 months', 'description': 'Urinary protein excretion\\<0.3 g/d (uPCR\\<300 mg/g or \\<30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal SCr.'}, {'measure': 'Partial Remission', 'timeFrame': 'after treatment for 6 months', 'description': 'Urinary protein excretion \\<3.5 g/d (uPCR \\<3500 mg/g or \\<350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable SCr.'}], 'secondaryOutcomes': [{'measure': 'estimated Glomerular filtration rate and serum creatinine', 'timeFrame': 'after treatment for 6 months', 'description': 'time to a 50% reduction in baseline estimated Glomerular filtration rate (according to CK-EPI) and to doubling of baseline creatinine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Idiopathic Membranous Nephropathy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) Patients who provided informed consent\n* (2) Patients who are diagnosed as membranous nephropathy by renal biopsy\n* (3) 18 years of age or older, male or female\n\nExclusion Criteria:\n\n* (1) identification of Secondary factors such as infectious diseases, rheumatic diseases, tumors, drugs and so on\n* (2) Previous medicine history of immunosuppressive medication and corticosteroids\n* (3) Patients who are not expected to complete 6 months of follow-up'}, 'identificationModule': {'nctId': 'NCT03475602', 'briefTitle': 'Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Prospective Cohort Study of Membranous Nephropathy-associated Serological Antibody in Prediction of the Prognosis of Idiopathic Membranous Nephropathy', 'orgStudyIdInfo': {'id': 'GDREC2017318H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cyclophosphamide', 'description': 'Drug: Cyclophosphamide，CTX Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody', 'interventionNames': ['Diagnostic Test: PLA2R', 'Diagnostic Test: TSHD7A']}, {'label': 'Cyclosporin', 'description': 'Drug: Cyclosporin Determination of serum concentration of anti PLA2R antibody and anti TSHD7A antibody', 'interventionNames': ['Diagnostic Test: PLA2R', 'Diagnostic Test: TSHD7A']}], 'interventions': [{'name': 'PLA2R', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of serum concentration of anti PLA2R antibody', 'armGroupLabels': ['Cyclophosphamide', 'Cyclosporin']}, {'name': 'TSHD7A', 'type': 'DIAGNOSTIC_TEST', 'description': 'Determination of serum concentration of anti TSHD7A antibody', 'armGroupLabels': ['Cyclophosphamide', 'Cyclosporin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nephrology Dept,Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}