[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584264":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":90,"collaborators":25,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":25,"enrollmentInfo":101,"targetDuration":25,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":120,"whyStopped":25,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Frail Patients","ACTIVE_COMPARATOR","Frailty will be measured clinically using reference criteria in the general population and validated in Kidney Transplantation (KT), i.e. predictive of post-KT complications: delayed recovery of graft function, graft function, early re-hospitalization, occurrence of post-operative confusion, mortality.\n\nFragile patients present at least 3 out of 5 criteria",[13,14],"Biological: Blood sample","Behavioral: Geriatric assessment standardized",{"label":16,"type":10,"description":17,"interventionNames":18},"non frail patients","Patients will be considered non-fragile if they present 0 to 2 criteria",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Blood sample","* Immunophenotyping of peripheral lymphocytes, with a focus on proportions of naïve \u002F central memory \u002F effector memory \u002F TEMRA cells, and markers of activation and senescence\n* Serum inflammatory markers : CRP, IL-6, MCP-1, TNF, sTNFR1\n* Single Molecule Array for IL1 and LUMINEX for IL18 in patient's sera\n* RT-qPCR for inflammasomes genes (NLRP3, NLRC4, NLRC5, AIM2, ASC, casp1, IL1b, IL18) expression among peripheral blood mononuclear cells\n* Assembly of the inflammasome platform will be measured in monocytes using intra-cellular staining of the ASC protein and flow cytometry",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"BEHAVIORAL","Geriatric assessment standardized","* Exhaustion (2 standardized questions)\n* Physical activity \\\u003C383 kcal\u002Fweek (men) or \\\u003C270 kcal\u002Fweek (women), measured using a standardized questionnaire (IPAQ)\n* 4-meters gait speed, with sex and height-specific cutoffs\n* Handgrip strength, measured using a dynamometer, with sex and BMI-sp Comorbidity (CIRS-G score )\n* Screening for intrinsic capacity decline (first step of ICOPE program, adapted to the study, )\n* Physical performance (SPPB score )\n* Cognitive functions (MoCA score ),\n* Depression (GDS-15 score ),\n* Nutrition (MNA score )\n* Sensory functions (Snellen test for vision, HHIES questionnaire for hearing) -- Dependency in activities of daily living (ADL and IADL scores)",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Florent GUERVILLE, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","05 57 65 65 53","+33","florent.guerville@chu-bordeaux.fr",[42,61,75],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CHU de Bordeaux - Hôpital Pellegrin -","Bordeaux","France","33076","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.58046,44.84124,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":39,"email":58},"Lionel COUZI, MD, PhD","0556796107","lionel.couzi@chubordeaux.fr",{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},"Lionel COUZI, MD; PhD",{"facility":62,"status":25,"city":63,"state":45,"zip":64,"country":45,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHU de Bordeaux, Hôpital Xavier Arnozan- Gérontologie Clinique","Pessac","33600",{"type":49,"coordinates":66},[67,68],-0.6324,44.80565,{"lat":68,"lon":67},[71,74],{"name":33,"role":37,"phone":72,"phoneExt":39,"email":73},"05 57 65 65 13","florent.guerville@chubordeaux.fr",{"name":33,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":76,"status":25,"city":77,"state":45,"zip":78,"country":45,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"CHU de Toulouse - Hôpital Rangueil","Toulouse","31059",{"type":49,"coordinates":80},[81,82],1.44367,43.60426,{"lat":82,"lon":81},[85,89],{"name":86,"role":37,"phone":87,"phoneExt":39,"email":88},"Aliénor Galinier, MD","0561323379","galinier.al@chutoulouse.fr",{"name":86,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":91,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100584264","systemic-activation-of-inflammasomes-and-frailty-in-older-candidates-to-kidney-transplantation-100584264",false,"NCT06887075","Systemic Activation of Inflammasomes and Frailty in Older Candidates to Kidney Transplantation","INTRA","* Inclusion criteria:\n\n  * Age ≥ 70\n  * Patient candidate to kidney transplantation (during assessment for inscription on the waiting-list, or during waiting time after effective inscription), without absolute contraindication\n  * Free, informed and written consent signed by the participant and the investigator (at the latest, on the day of inclusion and before any examination required by the research).\n  * Person affiliated or beneficiary of a social security scheme\n* Exclusion criteria:\n\n  * Inclusion in an industrial study refusing co-inclusion in our study\n  * Person under guardianship, assisted decision-making or under temporary guardianship","ALL","70 Years",{"count":102,"type":103},60,"ESTIMATED","INTERVENTIONAL",[106],"NA","Kidney transplantation (KT) benefit-risk ratio assessment is a challenge in a growing population of older patients with end-stage kidney disease. A pre-KT frailty phenotype has been found predictive of post-KT complications, but biological mechanisms of frailty are poorly known is these patients. Frailty is associated with chronic low-grade inflammation in the older general population, possibly through the inflammasome pathway. Our main objective is to assess if systemic activation of inflammasomes is associated with frailty in older candidates to KT.",[109,110,111,112],"Chronic Kidney Failure","Frailty","Aging","Inflammation",[114,115,116,117,118,119,110],"Older persons","End-stage kidney disease","Kidney transplantation","Immune aging","Chronic low-grade inflammation","Inflammasomes","NOT_YET_RECRUITING","2025-03-14",{"date":123,"type":124},"2025-03-20","ACTUAL",{"date":126,"type":103},"2025-04-15",{"date":128,"type":103},"2027-02-15",{"name":5,"class":6},3]