[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566393":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":36,"responsibleParty":54,"collaborators":58,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":11,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":11,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":11,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Telitacicept+ACEI\u002FARB","EXPERIMENTAL",null,[13],"Drug: Telitacicept 240mg",{"label":15,"type":16,"description":11,"interventionNames":17},"Glucocorticoids+ACEI\u002FARB","ACTIVE_COMPARATOR",[18],"Drug: Glucocorticoid",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Telitacicept 240mg","Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and\u002For angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Glucocorticoid","Patients in glucocorticoid group will be treated with ACEI\u002FARB and glucocorticoid ( prednisone\u002Fprednisolone) 0.5mg\u002Fkg (maximum 40mg\u002Fd). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Jingyuan Xie","CONTACT","+86-64370045","665232","nephroxie@163.com",[37],{"facility":5,"status":38,"city":39,"state":11,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Shanghai","200025","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":11,"email":53},"Jieming Qu","+86-021-64370045","partyoffice@rjh.com.cn",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Xie Jingyuan, MD","Chief physician",[59,61,63,65,67,69,72,74,76,78,80],{"name":60,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"name":62,"class":6},"RenJi Hospital",{"name":64,"class":6},"Sichuan Provincial People's Hospital",{"name":66,"class":6},"Renmin Hospital of Wuhan University",{"name":68,"class":6},"Shanghai 6th People's Hospital",{"name":70,"class":71},"Shanghai Longhua Hospital","UNKNOWN",{"name":73,"class":6},"Huashan Hospital",{"name":75,"class":6},"Shanghai Changzheng Hospital",{"name":77,"class":6},"Wannan Medical College Yijishan Hospital",{"name":79,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":81,"class":82},"Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine","OTHER_GOV","100566393","efficacy-and-safety-of-telitacicept-in-igan-100566393",false,"NCT06654596","Efficacy and Safety of Telitacicept in IgAN","A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy","Inclusion Criteria:\n\n1. 18-70 years old, male or female\n2. Primary IgA nephropathy confirmed by renal biopsy.\n3. Urine protein ≥ 0.75g\u002F24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g\u002Fg.\n4. eGFR ≥ 25 ml\u002Fmin\u002F1.73 m2 calculated using the CKD-EPI formula.\n5. Received treatment with ACEI\u002FARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.\n6. Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.\n7. Voluntarily participated in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with abnormal laboratory indicators (see study protocol for details).\n2. Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.\n3. Use of systemic glucocorticoids\u002Fimmunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).\n4. Use of biological agents within 6 months (rituximab, etc.).\n5. Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.\n6. COVID-19 infection within 2 weeks before randomization.\n7. Live vaccine within 4 weeks before randomization.\n8. History of malignant tumor within five years.\n9. Uncontrolled hypertension (systolic blood pressure\\>140mmHg or diastolic blood pressure\\>90mmHg).\n10. Poorly controlled diabetes (glycosylated hemoglobin\\>8%).\n11. Pregnant women and breastfeeding women.\n12. Participating in other clinical trials at the same time.\n13. Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.\n14. Other reasons judged by researchers as unsuitable for inclusion in the study.","ALL","18 Years","70 Years",{"count":94,"type":95},118,"ESTIMATED","INTERVENTIONAL",[98],"NA","A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.",[101,102,103,26],"IgA Nephropathy (IgAN)","Kidney Diseases","Telitacicept","2024-12-30",{"date":106,"type":107},"2025-01-01","ACTUAL",{"date":109,"type":107},"2024-12-06",{"date":111,"type":95},"2026-12",{"name":5,"class":6},1]