[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100425741":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":120,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":34,"enrollmentInfo":135,"targetDuration":34,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":52,"whyStopped":34,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",[8,13,17,20,23,26],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients without renal insufficiency under pazopanib","Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.",[12],"Other: blood sampling for ITK dosage",{"label":14,"type":6,"description":15,"interventionNames":16},"Patients without renal insufficiency under cabozantinib","Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.",[12],{"label":18,"type":6,"description":10,"interventionNames":19},"Patients with moderate renal impairment under pazopanib",[12],{"label":21,"type":6,"description":15,"interventionNames":22},"Patients with moderate renal impairment under cabozantinib",[12],{"label":24,"type":6,"description":10,"interventionNames":25},"Patients with severe or terminal stage renal impairment under pazopanib",[12],{"label":27,"type":6,"description":15,"interventionNames":28},"Patients with severe or terminal stage renal impairment under cabozantinib",[12],[30],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"blood sampling for ITK dosage","Blood sample for ITK dosage at visit 1 (1 month +\u002F- 1 week after the start of treatment) and at visit 2 (3 months +\u002F- 1 month after the start of treatment)",[21,18,27,24,14,9],null,[36],{"name":37,"affiliation":38,"role":39},"Fanny LEENHARDT, Dr","Institut du Cancer de Montpellier (ICM)","PRINCIPAL_INVESTIGATOR",[41,47],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Aurore MOUSSION","CONTACT","04 67 61 31 02","+33","DRCI-icm105@icm.unicancer.fr",{"name":48,"role":43,"phone":44,"phoneExt":45,"email":46},"Emmanuelle TEXIER",[50,68,82,92,106],{"facility":51,"status":52,"city":53,"state":34,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"APHM Hôpital LA TIMONE","RECRUITING","Marseille","13005","France","FR",{"type":58,"coordinates":59},"Point",[60,61],5.38107,43.29695,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":66,"phoneExt":45,"email":67},"Laurent DEVILLE, Dr","04 91 38 57 08","jean-laurent.deville@ap-hm.fr",{"facility":69,"status":52,"city":70,"state":34,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"CHU Montpellier - Hôpital St Eloi","Montpellier","34295",{"type":58,"coordinates":73},[74,75],3.87635,43.61093,{"lat":75,"lon":74},[78],{"name":79,"role":43,"phone":80,"phoneExt":45,"email":81},"Delphine TOPART, Dr","04 67 33 01 37","d-topart@chu-montpellier.fr",{"facility":83,"status":52,"city":70,"state":34,"zip":84,"country":55,"countryCode":56,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"ICM Val d'Aurelle","34298",{"type":58,"coordinates":86},[74,75],{"lat":75,"lon":74},[89],{"name":37,"role":43,"phone":90,"phoneExt":45,"email":91},"04 67 61 24 77","Fanny.Leenhardt@icm.unicancer.fr",{"facility":93,"status":52,"city":94,"state":34,"zip":95,"country":55,"countryCode":56,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"CHU de Nîmes, Institut de Cancérologie du Gard","Nîmes","30029",{"type":58,"coordinates":97},[98,99],4.35788,43.83665,{"lat":99,"lon":98},[102],{"name":103,"role":43,"phone":104,"phoneExt":45,"email":105},"Nadine HOUEDE, Pr","04 66 68 33 01","nadine.houede@chu-nimes.fr",{"facility":107,"status":52,"city":108,"state":34,"zip":109,"country":55,"countryCode":56,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole","Toulouse","31059",{"type":58,"coordinates":111},[112,113],1.44367,43.60426,{"lat":113,"lon":112},[116],{"name":117,"role":43,"phone":118,"phoneExt":45,"email":119},"Loïc MOUREY, Dr","05 31 15 51 67","mourey.loic@iuct-oncopole.fr",{"type":121,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[123],{"name":124,"class":6},"Ligue contre le cancer, France","100425741","impact-of-chronic-renal-failure-on-plasma-exposure-of-kinase-inhibitors-in-patients-treated-for-metastatic-kidney-cancer-100425741",false,"NCT04823923","Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer","Study of the Impact of the Stage of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors (ITK) in Patients Treated for Metastatic Kidney Cancer","IREKI","Inclusion Criteria:\n\n1. Patient followed for metastatic clear cell renal cell carcinoma.\n2. Age ≥18 years old.\n3. Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2\n4. Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer.\n5. If patient doesn't have renal failure -\\> group 1, or if patient has chronic renal failure according to the moderate stage Chronic Kidney Disease - Epidemiology (CKD-EPI) formula (Clr \\\u003C60 ml \u002F min, stage 3) -\\> group 2, or if patient have chronic renal failure according to the CKD-EPI formula of severe or terminal stage (Clr \\\u003C30 ml \u002F min, stage 4 and stage 5), with or without dialysis -\\> group 3.\n6. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n7. Patient having given informed, written and express consent.\n8. Affiliation to the French Social Security System.\n\nExclusion Criteria:\n\n1. Indication other than clear cell renal cell carcinoma for these same ITKs\n2. Pregnant or breast-feeding subjects\n3. Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons,\n4. Patient under guardianship, curatorship or safeguard of justice\n5. Participation in another clinical study with a research product during the last 30 days before inclusion.","ALL","18 Years",{"count":136,"type":137},60,"ESTIMATED","INTERVENTIONAL",[140],"NA","The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.",[143],"Kidney Neoplasm",[145,146,147,148],"metastatic kidney cancer","pazopanib","cabozantinib","renal failure","2025-02-11",{"date":151,"type":152},"2025-02-12","ACTUAL",{"date":154,"type":152},"2021-12-06",{"date":156,"type":137},"2026-03",{"name":5,"class":6},5]