[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547217":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":41,"locations":40,"responsibleParty":47,"collaborators":51,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":40,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":40,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":40,"overallStatus":81,"whyStopped":40,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":40},{"fullName":5,"class":6},"Air Force Military Medical University, China","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Supportive care+Prednisolone",[13],"Drug: Supportive care+Prednisone",{"label":15,"type":10,"description":16,"interventionNames":17},"Test group 1","Supportive care+Tacrolimus+Ripertamab",[18],"Drug: Supportive care+Tacrolimus+Ripertamab",{"label":20,"type":10,"description":21,"interventionNames":22},"Test group 2","Supportive care+Ripertamab",[23],"Drug: Supportive care+Ripertamab",[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Supportive care+Prednisone","Supportive care: Control blood pressure:ACEI\u002FARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.\n\nInduction period: 1mg\u002Fkg\u002Fday. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks.\n\nMaintenance period: A reduction of 5-10mg\u002Fwk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg\u002Fday.",[9],[31],"Control group",{"type":26,"name":16,"description":33,"armGroupLabels":34,"otherNames":35},"Supportive care: Control blood pressure:ACEI\u002FARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.\n\nTacrolimus：Induction period: 0.05mg\u002Fkg\u002Fd. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng\u002Fml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng\u002Fml, and stopped after 6 months of maintenance treatment.\n\nRipertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.",[15],[15],{"type":26,"name":21,"description":37,"armGroupLabels":38,"otherNames":39},"Supportive care: Control blood pressure:ACEI\u002FARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.\n\nRipertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.",[20],[20],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"shiren Sun[Author], Doctor","CONTACT","18729387675","272844142@qq.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Shiren sun","Chief",[52,54,56,58,60],{"name":53,"class":6},"First Affiliated Hospital Xi'an Jiaotong University",{"name":55,"class":6},"Second Affiliated Hospital of Xi'an Jiaotong University",{"name":57,"class":6},"The Second Affiliated Hospital of Air Force Military Medical University",{"name":59,"class":6},"Shaanxi Provincial People's Hospital",{"name":61,"class":6},"Shaanxi Provincial Hospital of Chinese Medicine","100547217","phase-3-efficacy-and-safety-of-tacrolimus-in-combination-with-ripertamab-in-the-initial-treatment-of-patients-with-mcd-100547217",false,"NCT06405100","Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD","Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 18-80 years old;\n2. Primary minimal change disease confirmed by renal biopsy (Initial therapy);\n3. 24h-UTP\\>3.5g\u002Fd or PCR\\>3500mg\u002Fg, and serum albumin\\\u003C30g\u002FL;\n4. Agree to participate in the project and sign the informed consent.\n\nExclusion Criteria:\n\n1. Secondary minimal change disease;\n2. eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2;\n3. Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;\n4. Active bleeding in the gastrointestinal tract;\n5. Prior treatment with corticosteroids or other immunosuppressants;\n6. HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;\n7. Have been vaccinated with live vaccine in the past four weeks;\n8. Serum bilirubin \\> 3.6mg\u002Fdl for at least 1 month or liver function ≥3 times the upper limit of normal value;\n9. Allergic to prednisolone, tacrolimus, or ripertamab;\n10. Reluctance to use contraception or plan pregnancy\u002Flactation within 6 months of study completion;\n11. Had history of alcohol\u002Fdrug abuse;\n12. Unable to give informed consent.","ALL","18 Years","80 Years",{"count":73,"type":74},81,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.",[80],"Minimal Change Disease","NOT_YET_RECRUITING","2024-05-04",{"date":84,"type":85},"2024-05-08","ACTUAL",{"date":87,"type":74},"2024-05",{"date":89,"type":74},"2027-04",{"name":5,"class":6}]