[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648104":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":38,"centralContacts":43,"locations":37,"responsibleParty":49,"collaborators":37,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":37,"enrollmentInfo":63,"targetDuration":37,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":83,"whyStopped":37,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":37},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: CD38 mAb Induction + Azathioprine Sequential Maintenance","EXPERIMENTAL","All enrolled caABMR patients receive:\n\n* Single subcutaneous injection of CD38 monoclonal antibody 1800 mg at baseline (Day 0).\n* Immediate conversion from mycophenolate mofetil to azathioprine (AZA), dosed according to TPMT\u002FNUDT15 genotype and adjusted to achieve NK cell count \\\u003C20\u002FμL.\n* Continued standard triple immunosuppression: corticosteroid + azathioprine + tacrolimus (trough 5-7 ng\u002FmL) or cyclosporine (trough 150-250 ng\u002FmL).\n* Protocol-driven monitoring and 28-week surveillance biopsy. No control arm (single-arm exploratory design justified by lack of approved therapy and emerging evidence for CD38 targeting in AMR).",[13,14,15],"Biological: CD38","Drug: Azathioprine (AZA)","Other: Standard Triple Immunosuppression Maintenance",[17,25,33],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BIOLOGICAL","CD38","Single 1800 mg subcutaneous injection at baseline to induce rapid depletion of plasma cells (source of DSA) and NK cells (key effectors of microvascular injury in caABMR). Marketed anti-CD38 mAb (off-label use in this indication).",[9],[23,24],"CD38 mAb","anti-CD38 monoclonal antibody",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Azathioprine (AZA)","Oral azathioprine maintenance (replaces mycophenolate), individualized starting dose 2.0-3.0 mg\u002Fkg\u002Fday (normal TPMT\u002FNUDT15 metabolizer) or 30-80% reduced (intermediate metabolizer), titrated per serial NK cell counts and hematologic tolerance. Long-term NK suppression to maintain immune balance and protect graft.",[9],[31,32],"AZA","Imuran (or generic)",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Standard Triple Immunosuppression Maintenance","Continued per local practice with protocol targets",[9],null,[39],{"name":40,"affiliation":41,"role":42},"Jianyong Wu, MD","Zhejiang University","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":37,"email":48},"Chunchun Wei, MD","CONTACT","+8613738053172","327530957@qq.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","wujianyong","Director, Nephrology Center \u002F Chief Physician","100648104","cd38-mab-induction--azathioprine-maintenance-for-chronic-active-amr-in-kidney-transplant-recipients-100648104",false,"NCT07718308","CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients","A Multicenter Exploratory Clinical Study of Targeted NK Cell Inhibition for Transplant Kidney Chronic Active Antibody-Mediated Rejection (caABMR): Single Induction With CD38 Monoclonal Antibody Followed by Sequential Maintenance With Azathioprine","CAZA","Inclusion Criteria:\n\n1. Voluntary written informed consent.\n2. Age ≥18 years.\n3. Kidney transplant (living or deceased donor) ≥180 days prior.\n4. eGFR ≥30 mL\u002Fmin\u002F1.73 m² (CKD-EPI 2021).\n5. Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects.\n6. Positive HLA Class I and\u002For Class II donor-specific antibodies (DSA).\n7. Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR).\n8. TPMT\u002FNUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer).\n\nExclusion Criteria:\n\n1. Participating in another clinical trial.\n2. Age \\\u003C18 years.\n3. Pregnant, breastfeeding, or inadequate contraception in females.\n4. ABO-incompatible transplant.\n5. TPMT\u002FNUDT15 homozygous mutant genotype.\n6. Biopsy shows any of: T-cell mediated rejection (TCMR), new\u002Frecurrent severe thrombotic microangiopathy, or polyomavirus nephropathy.\n7. Received anti-rejection therapy in prior 3 months.\n8. Received other immunomodulatory monoclonal\u002Fpolyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6\u002FIL-6R) in prior 3 months.\n9. Total bilirubin \\>2×ULN or ALT\u002FAST \\>2.5×ULN.\n10. Hemoglobin \\\u003C8 g\u002FdL.\n11. Platelets \\\u003C100×10\\^9\u002FL.\n12. WBC \\\u003C3×10\\^9\u002FL or neutrophils \\\u003C1.5×10\\^9\u002FL.\n13. Hypogammaglobulinemia: IgG \\\u003C400 mg\u002FdL.\n14. Active bacterial, viral, or fungal infection.\n15. Active malignancy requiring intensified immunosuppression.\n16. Latent or active tuberculosis.\n17. Live vaccine within 6 weeks of screening.\n18. History of alcohol or illicit drug abuse.\n19. Severe medical or psychiatric illness likely to impair study participation.\n20. Active hepatitis B.\n21. Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.","ALL","18 Years",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[68],"NA","This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38 monoclonal antibody (1800 mg subcutaneous) induction to deplete plasma cells and NK cells, followed by long-term maintenance with azathioprine (replacing mycophenolate mofetil) plus standard triple immunosuppression (steroid + calcineurin inhibitor). The regimen aims to control DSA-driven injury, stabilize or improve graft function (primary: eGFR decline slope), reduce DSA, improve pathology (Banff 2022), and minimize infection\u002Fnephrotoxicity risks associated with intensified or prolonged biologic therapy. Twenty patients across 6 Chinese transplant centers will be enrolled. CD38 mAb, azathioprine, key monitoring tests (HLA antibody, pharmacogenomics, immune profiling) are provided free by the study team (\\~40,000 RMB per patient). Ethics approved; informed consent obtained.",[71,72],"Kidney Transplantation","Antibody-mediated Rejection",[74,75,76,77,78,79,80,81,82],"Daratumumab","Banff 2022 classification","Azathioprine","Natural killer cell","Donor specific antibody","eGFR slope","Chronic active AMR","CD38 antibody","Sequential immunosuppression","NOT_YET_RECRUITING","2026-07-16",{"date":86,"type":87},"2026-07-21","ACTUAL",{"date":89,"type":65},"2026-07-15",{"date":91,"type":65},"2028-03-15",{"name":51,"class":6}]