[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":44,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Mario Negri Institute for Pharmacological Research","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Perfusion and concomitant adsorption","EXPERIMENTAL","Kidneys eligible for perfusion will be treated with the PerLife PerKidney system. Kidneys allocated to the adsorption subgroup will receive concomitant treatment with PerSorb cartridge.",[13,14],"Device: PerSorb cartridge (CytoSorbents Europe GmbH, Germany)","Device: PerLife PerKidney",{"label":16,"type":17,"description":18,"interventionNames":19},"Perfusion alone","ACTIVE_COMPARATOR","Kidneys eligible here will only be treated with the PerLife PerKidney system.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","PerSorb cartridge (CytoSorbents Europe GmbH, Germany)","This is a highly bio-\u002Fhemo-compatible, low-flow resistance polymer cartridge able to remove cytokines and other inflammatory mediators via adsorption.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PerLife PerKidney","The system for ex vivo kidney reconditioning (Aferetica, Italy), which allows hypothermic oxygenated pulsatile perfusion of the organ.",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Giuseppe Remuzzi, MD","Istituto Di Ricerche Farmacologiche Mario Negri","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Camillo Carrara, MD","CONTACT","+3903545351","pruggenenti@asst-pg23.it",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":41},"Piero L Ruggenenti, MD",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi\u002F Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò","RECRUITING","Bergamo","BG","24027","Italy","IT",{"type":54,"coordinates":55},"Point",[56,57],9.66721,45.69601,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Piero Ruggenenti, MD","0039 035 45351","piero.ruggenenti@marionegri.it",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100544840","kidney-perfusion-with-or-without-absorption-100544840",false,"NCT06374121","Kidney Perfusion With or Without Absorption","A Single-center, Pilot, Prospective, Randomized Clinical Study of Hypothermic Oxygenated Perfusion With or Without Adsorption in Histologically Evaluated Kidneys Retrieved From Marginal Donors","POWER","Inclusion Criteria:\n\n* Males and females older than 50 years eligible for single or dual kidney transplant from marginal donors identified according to the NITp criteria (\\>70-year-old or 60 to 70 years with hypertension and\u002For diabetes and\u002For clinical proteinuria)\n* Pre-transplant histological evaluation\n* Histological score ≤ 7\n* Written informed consent.\n\nExclusion Criteria:\n\n* Any factor that represents a contraindication to receive a deceased donor kidney transplant according to the NITp criteria,\n* Need for specific desensitization protocols because of a high immunological risk according to the NITp criteria,\n* Active enrollment in concomitant intervention studies,\n* Macroscopic vascular abnormalities that preclude the possibility of machine perfusion.","ALL","50 Years",{"count":77,"type":78},10,"ESTIMATED","INTERVENTIONAL",[81],"NA","In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and \"PerSorb ECOS-300CY ™\" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \\>70-years-old or aged 60 to 69 years but with hypertension, diabetes and\u002For clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice.",[84],"Kidney Replacement",[86,87,88],"Kidney perfusion","Absorption","Marginal donors","2024-11-21",{"date":91,"type":92},"2024-11-22","ACTUAL",{"date":94,"type":92},"2024-10-22",{"date":96,"type":78},"2026-05",{"name":5,"class":6},1]