[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405638":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":40,"responsibleParty":187,"collaborators":190,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":208,"sex":214,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":18,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":100,"whyStopped":18,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Standard of care (SOC) + tocilizumab (TCZ)","ACTIVE_COMPARATOR","SOC, as below + TCZ (162 mg every week, subcuataneous administration)",[13],"Drug: Tocilizumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B: SOC","NO_INTERVENTION","Tacrolimus (target concentration 6 ±1 µg\u002FL) + MPA (1.5-2 g\u002Fday as tolerated) + prednisolone (not less than 5 mg\u002Fday), all oral administration",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tocilizumab","Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor",[9],[26],"RoActemra",[28],{"name":29,"affiliation":30,"role":31},"Seema Baid-Agrawal, MD, FASN","Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","+4631-342 10 00","seema.baid-agrawal@vgregion.se",{"name":38,"role":34,"phone":35,"phoneExt":18,"email":39},"Marie Felldin, MD, PhD","marie.felldin@surgery.gu.se",[41,60,69,83,98,116,150,168],{"facility":42,"status":43,"city":44,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Complejo Hospitalario Universitario A Coruña","NOT_YET_RECRUITING","A Coruña","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],-8.396,43.37135,{"lat":51,"lon":50},[54,58],{"name":55,"role":34,"phone":56,"phoneExt":18,"email":57},"Constantino Fernández Rivera, MD. PhD","+34 981 178 159","Constantino.Fernandez.Rivera@sergas.es",{"name":59,"role":31,"phone":18,"phoneExt":18,"email":18},"Constantino Fernández Rivera, MD, PhD",{"facility":61,"status":62,"city":63,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":18},"Hospital del Mar","ACTIVE_NOT_RECRUITING","Barcelona",{"type":48,"coordinates":65},[66,67],2.15899,41.38879,{"lat":67,"lon":66},{"facility":70,"status":43,"city":71,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Marqués de Valdecilla Research Institute","Santander",{"type":48,"coordinates":73},[74,75],-3.80493,43.46589,{"lat":75,"lon":74},[78,82],{"name":79,"role":34,"phone":80,"phoneExt":18,"email":81},"Juan Carlos Ruíz San Millán, MD. PhD","+34 942 202738","juancarlos.ruiz@scsalud.es",{"name":79,"role":31,"phone":18,"phoneExt":18,"email":18},{"facility":84,"status":43,"city":85,"state":18,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hospital Universitario Dr. Peset","Valencia",{"type":48,"coordinates":87},[88,89],-0.37966,39.47391,{"lat":89,"lon":88},[92,96],{"name":93,"role":34,"phone":94,"phoneExt":18,"email":95},"Asunción Sancho Calabuig, MD, PhD","+34 648 012 408","asanchoc2@gmail.com",{"name":97,"role":31,"phone":18,"phoneExt":18,"email":18},"Asunción Sancho Calabuig, MD. PhD",{"facility":99,"status":100,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Skåne University Hospital","RECRUITING","Malmö","Skåne County","214 28","Sweden","SE",{"type":48,"coordinates":107},[108,109],13.00073,55.60587,{"lat":109,"lon":108},[112,115],{"name":113,"role":34,"phone":18,"phoneExt":18,"email":114},"Carin Wallquist, MD, PhD","Carin.Wallquist@skane.se",{"name":113,"role":31,"phone":18,"phoneExt":18,"email":18},{"facility":117,"status":100,"city":118,"state":119,"zip":18,"country":104,"countryCode":105,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Transplant Center, Sahlgrenska University Hospital","Gothenburg","Vastra Gotaland Regioin",{"type":48,"coordinates":121},[122,123],11.96679,57.70716,{"lat":123,"lon":122},[126,129,130,133,135,137,138,140,142,144,146,148],{"name":127,"role":34,"phone":128,"phoneExt":18,"email":36},"Seema Baid-Agrawal, MD","031-342 10 00",{"name":38,"role":34,"phone":128,"phoneExt":18,"email":39},{"name":131,"role":132,"phone":18,"phoneExt":18,"email":18},"Jana Ekberg, MD","SUB_INVESTIGATOR",{"name":134,"role":132,"phone":18,"phoneExt":18,"email":18},"Lars Mjornstedt, MD, PhD",{"name":136,"role":132,"phone":18,"phoneExt":18,"email":18},"Per Lindnér, MD, PhD",{"name":38,"role":132,"phone":18,"phoneExt":18,"email":18},{"name":139,"role":132,"phone":18,"phoneExt":18,"email":18},"Lillian Streichart, MD",{"name":141,"role":132,"phone":18,"phoneExt":18,"email":18},"Annette Lennerling, RN, PhD",{"name":143,"role":132,"phone":18,"phoneExt":18,"email":18},"Verena Bröcker, MD",{"name":145,"role":132,"phone":18,"phoneExt":18,"email":18},"Johan Mölne, MD, PhD",{"name":147,"role":132,"phone":18,"phoneExt":18,"email":18},"Jan Holgersson, MD, PhD",{"name":149,"role":132,"phone":18,"phoneExt":18,"email":18},"Jenny Nyström, MD, PhD",{"facility":151,"status":100,"city":152,"state":18,"zip":153,"country":104,"countryCode":105,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Karolinksa University Hospital","Stockholm","SE-141 86",{"type":48,"coordinates":155},[156,157],18.06871,59.32938,{"lat":157,"lon":156},[160,164,166],{"name":161,"role":34,"phone":162,"phoneExt":18,"email":163},"Lars Wennberg, MD, PhD","+46 8 5858 2554","lars.wennberg@sll.se",{"name":165,"role":31,"phone":18,"phoneExt":18,"email":18},"Lars Wennberg, MD. PhD",{"name":167,"role":132,"phone":18,"phoneExt":18,"email":18},"Jessica Smolander, MD",{"facility":169,"status":100,"city":170,"state":18,"zip":171,"country":104,"countryCode":105,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Uppsala University Hospital","Uppsala","751 85",{"type":48,"coordinates":173},[174,175],17.63889,59.85882,{"lat":175,"lon":174},[178,182,185],{"name":179,"role":34,"phone":180,"phoneExt":18,"email":181},"Tomas Lorant, MD, PhD","+46 18 611 7080","Tomas.Lorant@surgsci.uu.se",{"name":183,"role":34,"phone":18,"phoneExt":18,"email":184},"Bengt Felldström, MD, PhD","bengt.fellstrom@medsci.uu.se",{"name":186,"role":31,"phone":18,"phoneExt":18,"email":18},"Tomas Lorant, MD. PhD",{"type":31,"investigatorFullName":188,"investigatorTitle":189,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Seema Baid-Agrawal","Associate Professor and Consultant Nephrologist, Transplantation Center, Sahlgrenska University Hospital, Gothenburg",[191,194,195,197,199,200,202,204],{"name":192,"class":193},"Karolinska University Hospital","OTHER",{"name":169,"class":193},{"name":196,"class":193},"Skane University Hospital",{"name":198,"class":6},"The Swedish Research Council",{"name":61,"class":193},{"name":201,"class":193},"Hospital Universitario Doctor Peset",{"name":203,"class":193},"Complexo Hospitalario Universitario de A Coruña",{"name":205,"class":193},"Hospital Universitario Marqués de Valdecilla","100405638","phase-3-tocilizumab-in-latechronic-active-antibody-mediated-rejection-in-kidney-transplant-recipients-100405638",false,"NCT04561986","TocIlizumab in Late\u002FChronic Active Antibody-mediated Rejection in Kidney Transplant Recipients","A Randomized Controlled Open-label Multi-center Study to Assess the Efficacy of TCZ in Treatment of Late\u002FChronic Active Antibody-mediated Rejection in Kidney Transplant Recipients","INTERCEPT","Inclusion Criteria:\n\n1. The subject has given their written informed consent to participate in the study\n2. Recipient of living donor or deceased donor kidney transplant\n3. Age ≥18 years\n4. At least 6 months post-transplantation at randomization\n5. Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy\n6. eGFR ≥20 ml\u002Fmin\u002F1.73 m2\n7. Epstein-Barr Virus (EBV) IgG-positive\n8. For female participants of childbearing potential:\n\n   * use of adequate contraception and a negative pregnancy test\n9. Subject known to have COVID-19 previously must meet all of the following conditions:\n\n   * Asymptomatic for at least 1 month before the start of screening\n   * Re-established on background immunosuppressants for at least 1 month prior to the randomization\n\nExclusion Criteria:\n\n1. Recipient of multi-organ transplants\n2. De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction\n3. Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based on polymerase chain reaction (PCR) testing\n4. Ongoing serious infections as per Investigator's opinion\n5. History of recurrent infections requiring hospitalization\n6. Active tuberculosis (TB)\n7. Latent untreatedTB (positive QuantiFERON-TB-Gold test, Chest X-ray)\n8. Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin \\> 1.5 x upper limit of normal)\n9. Other significant liver disease as per Investigator's opinion\n10. Neutropenia (\\\u003C2 x109\u002FL) or thrombocytopenia (\\\u003C100 x109\u002FL)\n11. Signs of post-transplant lymphoproliferative disorder\n12. Signs of malignancy. Exceptions are basal cell carcinoma\u002Fsquamous cell carcinoma or non-malignant melanoma\n13. History of malignancy, unless subject has been considered to have fully recovered from malignancy since \\> 2 years, without any signs of relapse\n14. History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation\n15. Ongoing alcohol or illicit substance abuse\n16. Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator's opinion\n17. Mental inability or reluctance that results in difficulties in understanding the meaning of study participation\n18. Woman of childbearing potential who is unwilling\u002Funable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug\n19. Woman with a positive pregnancy test or who is pregnant or breastfeeding\n20. Current or recent (within last 3 months) participation in another clinical drug trial","ALL","18 Years","100 Years",{"count":218,"type":219},50,"ESTIMATED","INTERVENTIONAL",[222],"PHASE3","This multi-center study is an investigator-driven randomized controlled parallel group open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in reducing the decline of graft function in kidney transplant recipients with late or chronic antibody-mediated rejection (AMR). A total of 50 recipients will be allocated to receive either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24 months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies will be performed at 12 and 24 months. The primary outcome is the mean rate of change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope from baseline to 24 months after start of treatment.",[225],"Antibody-mediated Rejection",[227,228,229,230,231,232,233],"Kidney transplant","Chronic rejection","Antibody-mediated rejection","Graft function","Donor specific antibodies (DSA)","Transplant-specific well-being","Adherence","2025-03-31",{"date":236,"type":237},"2025-04-03","ACTUAL",{"date":239,"type":237},"2022-02-01",{"date":241,"type":219},"2028-12",{"name":5,"class":6},8]