[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394336":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":31,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":12,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Fundacion Clinic per a la Recerca Biomédica","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"1- Control group (Standard immunosuppression)","NO_INTERVENTION","1- Control group (n=15): Standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate), according to the clinical protocol of the Nephrology and Kidney Transplant Department.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"2- Treatment group (ECP+Standard immunosuppression)","EXPERIMENTAL","2- Treatment group (n=15): Extracorporeal photopheresis in combination with standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate) according to the clinical protocol of the Nephrology and Kidney Transplant Department",[18],"Other: Extracorporeal Photopheresis",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Extracorporeal Photopheresis","Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Diekmann","CONTACT","+34932275400","5444","fdiekman@clinic.cat",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Deparment of Nephology and Kidney Transplant","RECRUITING","Barcelona","Please Select","08036","Spain","ES",{"type":41,"coordinates":42},"Point",[43,44],2.15899,41.38879,{"lat":44,"lon":43},[47,50,52,54,57,59],{"name":48,"role":27,"phone":12,"phoneExt":12,"email":49},"Gastón J Piñeiro, MD","gjpineir@clinic.cat",{"name":51,"role":27,"phone":28,"phoneExt":29,"email":30},"Fritz Diekmann, MD, PhD",{"name":48,"role":53,"phone":12,"phoneExt":12,"email":12},"SUB_INVESTIGATOR",{"name":55,"role":56,"phone":12,"phoneExt":12,"email":12},"Fritz Diekmann, MD,PhD","PRINCIPAL_INVESTIGATOR",{"name":58,"role":53,"phone":12,"phoneExt":12,"email":12},"Jordi Rovira, PhD",{"name":60,"role":53,"phone":12,"phoneExt":12,"email":12},"Pedro Ventura, MD, PhD",{"type":56,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Fritz Diekmann","Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)",[65],{"name":66,"class":67},"Mallinckrodt","INDUSTRY","100394336","impact-of-photopheresis-in-the-prevention-of-acute-rejection-in-highly-sensitized-de-novo-kidney-transplant-recipients-100394336",false,"NCT04414735","Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients","Inclusion Criteria:\n\n* Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation\n* Recipients between 18 and 75 years old\n* Patients are able to understand and sign informed consent (Annex 1).\n\nExclusion Criteria:\n\n* Participation in another interventional clinical trial.\n* Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant.\n* Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.","ALL","18 Years","75 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"NA","The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).\n\nUnicentric, randomized, open study.",[85],"Kidney Transplant Rejection",[85,87,88,89],"photopheresis","Antibody-mediated rejection","Chronic active antibody-mediated rejection","UNKNOWN","2023-07-04",{"date":93,"type":94},"2023-07-06","ACTUAL",{"date":96,"type":94},"2022-08-17",{"date":98,"type":79},"2025-12",{"name":5,"class":6},1]