[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396169":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":10,"centralContacts":10,"locations":37,"responsibleParty":55,"collaborators":57,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":10,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14,19,22,25],{"label":9,"type":10,"description":11,"interventionNames":12},"IgAN patients at low risk of disease progression",null,"n = 30, incipient disease",[13],"Drug: Intervention for incipient patients at low risk of disease progression",{"label":15,"type":10,"description":16,"interventionNames":17},"IgAN patients at high risk of disease progression","n = 60, incipient disease",[18],"Drug: Intervention for patients at high risk of disease progression",{"label":20,"type":10,"description":21,"interventionNames":10},"Long-term stable patients","n = 30, follow-up for at least 15 years",{"label":23,"type":10,"description":24,"interventionNames":10},"Progressive IgAN patients","n = 30",{"label":26,"type":10,"description":24,"interventionNames":10},"Healthy control",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"DRUG","Intervention for incipient patients at low risk of disease progression","Conservative treatment, if necessary use ACEI\u002FARB and titrated to the maximum tolerated dose, with a BP-lowering goal of \\\u003C 130\u002F80 mm Hg",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Intervention for patients at high risk of disease progression","BP-lowering goal of \\\u003C 125\u002F75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:\n\n1. If GFR\\>60 ml\u002Fmin\u002F1.73m\\^2, oral prednisone 0.6-0.8 mg\u002Fkg\u002Fday ( (maximum dose 48 mg\u002Fday) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks.\n2. If GFR is 30-60 ml\u002Fmin\u002F1.73m\\^2, intravenous cyclophosphamide (CTX) 750 mg per month per m\\^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks.",[15],[38],{"facility":5,"status":39,"city":40,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Shanghai","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},"Jiang Gengru","CONTACT","+86-13917983703","jianggeng-ru@hotmail.com",{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[58,60,62],{"name":59,"class":6},"RenJi Hospital",{"name":61,"class":6},"Shanghai Zhongshan Hospital",{"name":63,"class":6},"Shanghai University of Traditional Chinese Medicine","100396169","the-applicaiton-of-immune-repertoire-in-the-diagnosis-and-disease-monitoring-of-iga-nephropathy-100396169",false,"NCT04438603","The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy","Inclusion Criteria:\n\n1\\. IgA nephropathy:\n\n1. Age: 18-80 years.\n2. Patients diagnosed with primary IgA nephropathy by renal biopsy.\n3. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula) ≥30ml\u002Fmin\u002F1.73\u002Fm\\^2.\n4. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity matched health volunteers. 3. IgAN patients were further divided into 4 groups, as defined below:\n\n1\\) Long-term stable patients:\n\nFollow-up for at least 15 years and meet at least one of the following:\n\n1. Annual eGFR loss rate \\\u003C3ml\u002Fmin\u002F1.73m\\^2.\n2. eGFR\\>90ml\u002Fmin\u002F1.73m\\^2. 2) Non-progressive IgAN patients:\n\nMeet at least one of the following:\n\n1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage).\n2. Annual eGFR loss rate \\>5ml\u002Fmin\u002F1.73m\\^2.\n3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria ≤ 1g\u002F24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of disease progression: Proteinuria \\> 1g\u002F24h despite 3 months of optimized supportive care.\n\nExclusion Criteria:\n\n1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;\n2. Patients with secondary IgAN;\n3. During pregnancy or lactation;\n4. After kidney transplantation;\n5. More than one serious acute infection in the psat 12 months;\n6. Chronic infection;\n7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months;\n8. Incomplete medical history or clinical data.",true,"ALL","18 Years","80 Years",{"count":75,"type":76},180,"ESTIMATED","OBSERVATIONAL","This prospective study aims to investigate the role of IR-Seq in the diagnosis and disease monitoring in patients with IgA nephropathy.",[80],"IgA Nephropathy",[80,82,83],"IR-Seq","Biomarker","UNKNOWN","2020-08-26",{"date":87,"type":88},"2020-08-28","ACTUAL",{"date":90,"type":76},"2020-10-01",{"date":92,"type":76},"2022-09-30",{"name":5,"class":6},1]