[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599179":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":47,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":24,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":36,"whyStopped":24,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Hospital, Martin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dara","ACTIVE_COMPARATOR","Kidney transplant recipients with late ABMR and de novo DSA treated with daratumumab (1800mg subcutaneous, weekly x 4, then monthly x 6).",[13],"Drug: Daratumumab (Subcutaneously)",{"label":15,"type":6,"description":16,"interventionNames":17},"control group","Kidney transplant recipients with late ABMR and de novo DSA treated with standard therapies (IVIG, plasmapheresis, rituximab, etc.) prior to the start of the daratumumab study.",[18],"Other: control group",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","Daratumumab (Subcutaneously)",[9],null,{"type":6,"name":15,"description":16,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Ivana Dedinska, prof, MD, PhD., MHA, FERA","CONTACT","+421 904 386 220","ivana.dedinska@uniba.sk",[34],{"facility":35,"status":36,"city":37,"state":24,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":24},"University hospital Martin","RECRUITING","Martin","03601","Slovakia","SK",{"type":42,"coordinates":43},"Point",[44,45],18.92399,49.06651,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Matej Vnucak","MD, PhD","100599179","daratumumab-for-late-antibody-mediated-rejection-100599179",false,"NCT07081126","Daratumumab for Late Antibody-Mediated Rejection","Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study","DARTABMR","Inclusion Criteria:\n\n* Kidney transplant recipient (first or subsequent transplant)\n* Diagnosis of late ABMR (diagnosed \\>12 months post-transplant)\n* Biopsy-proven ABMR\n* Presence of de novo DSA\n\nExclusion Criteria:\n\n* Active infection\n* Other significant comorbidities that could affect outcomes or treatment safety\n* Contraindications to daratumumab\n* Prior treatment with daratumumab\n* Specific types of DSA (consider specifying, e.g., unacceptable antigens)\n* Non-adherence to standardized immunosuppression protocol (tacrolimus, MMF, steroids)\n* iFTA 2 or 3 on baseline biopsy","ALL","18 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66],"NA","The study titled \"Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients with De Novo Donor-Specific Antibodies\" (DARTABMR) is a case-control investigation assessing whether daratumumab is more effective than standard therapies (such as IVIG, plasmapheresis, and rituximab) in treating late antibody-mediated rejection (ABMR) in kidney transplant patients with new donor-specific antibodies (DSA). The research compares outcomes like kidney function stabilization, DSA reduction, and biopsy improvements between patients receiving daratumumab and those on standard treatments. Participants include transplant recipients diagnosed with ABMR more than 12 months post-transplant, with data collected on clinical, immunological, and biopsy parameters before, during, and after treatment. The study emphasizes matching participants based on key variables to minimize bias and will analyze treatment success rates, changes in kidney function and DSA levels, and adverse events.",[69,70],"Kidney Tansplant","Acute Rejection (AR) of Transplanted Kidney",[72,73,74],"daratumumab","kidney transplant","acute antibody mediated rejection","2025-07-15",{"date":77,"type":78},"2025-07-23","ACTUAL",{"date":80,"type":78},"2025-07-01",{"date":82,"type":63},"2026-12-31",{"name":5,"class":6},1]