[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650295":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":31,"enrollmentInfo":76,"targetDuration":31,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":31,"overallStatus":85,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single arm","EXPERIMENTAL","This is a single-arm, before-and-after interventional study evaluating the implementation of URIKI within the nutritional care pathway of patients with stage 4 or 5 chronic kidney disease in routine clinical practice. Participants receive standard nephrology and dietetic care supplemented by the URIKI system, which includes connected urine test strips, a portable reader, the My URIKI mobile application, and a healthcare professional platform. Participants perform daily home urine measurements for 10 days and provide nutrition- and hydration-related information through the application. Outcomes collected after URIKI implementation are compared with data from a 6 months pre-intervention period representing conventional care without URIKI.",[13],"Device: URIKI Digital Urinary Monitoring System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","URIKI Digital Urinary Monitoring System","URIKI is a digital in vitro diagnostic system designed to support nutritional assessment in patients with stage 4 or 5 chronic kidney disease. The intervention includes connected urine test strips, a portable reader, the My URIKI mobile application, and a secure healthcare professional platform. Participants perform urine measurements at home once daily for 10 consecutive days and enter nutrition- and hydration-related information into the application, including meal information and patient-reported outcomes. Urinary biomarker results and patient-reported data are transmitted to authorized healthcare professionals and used to support nutritional assessment and personalized dietary follow-up. The intervention is delivered in addition to routine nephrology and dietetic care and is evaluated as part of the implementation of URIKI within the chronic kidney disease nutritional care pathway.",[9],[21],"My URIKI",[23],{"name":24,"affiliation":5,"role":25},"Corinne Isnard Bagnis","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Youcef Sekour","CONTACT","+33156095823",null,"youcef.sekour@aphp.fr",[34,50],{"facility":35,"status":31,"city":36,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie","Paris","France","FR",{"type":40,"coordinates":41},"Point",[42,43],2.3488,48.85341,{"lat":43,"lon":42},[46,49],{"name":24,"role":29,"phone":47,"phoneExt":31,"email":48},"0033142177211","corinne.bagnis@aphp.fr",{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"facility":51,"status":31,"city":36,"state":31,"zip":31,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie",{"type":40,"coordinates":53},[42,43],{"lat":43,"lon":42},[56,60],{"name":57,"role":29,"phone":58,"phoneExt":31,"email":59},"Jean-Jacques Boffa","0033156016029","jean-jacques.boffa@aphp.fr",{"name":57,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":62,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[64],{"name":65,"class":66},"SKEZI, IKI, DALI","UNKNOWN","100650295","assessment-of-dietary-balance-in-home-dwelling-patients-with-stage-4-and-5-chronic-kidney-disease-using-uriki-iki-a-connected-urine-test-strip-and-in-vitro-diagnostic-medical-device-100650295",false,"NCT07746037","Assessment of Dietary Balance in Home-Dwelling Patients With Stage 4 and 5 Chronic Kidney Disease Using URIKI (IKI), a Connected Urine Test Strip and In Vitro Diagnostic Medical Device","URIKI-MRC","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Chronic kidney disease (CKD) stage 4 or 5 with estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m².\n* Followed in a nephrology department within a structured care pathway that includes nutritional assessment.\n* Clinical indication or need for nutritional assessment as part of routine care.\n* Willing and able to use the URIKI device for nutritional assessment.\n* Able to understand French or English, or assisted by a caregiver capable of supporting device use and understanding study procedures.\n* Agreement to the use of the device and to the collection and transmission of study-related data.\n* Affiliation with a social security system or beneficiary of such coverage.\n* Access to a compatible smartphone, a smartphone provided by IKI, or assistance from a caregiver for use of the mobile application\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Severe cognitive impairment preventing understanding of study procedures or use of the application without caregiver assistance.\n* Major motor or sensory impairments (e.g., blindness, hemiplegia) preventing use of the device without caregiver assistance.\n* Inability to understand French or English without support from a caregiver or third party.\n* Refusal of the loaned smartphone or persistent inability to use the provided equipment despite support.\n* Refusal to participate in the study or withdrawal after receiving study information.\n* Concurrent participation in another interventional clinical study deemed incompatible with this study, or an ongoing exclusion period related to another study.\n* Individuals under legal protection (guardianship or curatorship), unless participation is authorized by the legal representative and ethics committee","ALL","18 Years",{"count":77,"type":78},450,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to evaluate whether the integration of URIKI, a connected urine test strip and in vitro diagnostic medical device, can improve the nutritional management of patients with stage 4 or 5 chronic kidney disease (CKD) living at home. The primary purpose is to assess whether URIKI can support dietary monitoring and optimize dietitians' workload through remote collection of urinary and nutrition-related data.\n\nThe main question it aims to answer is:\n\nDoes the integration of URIKI improve the efficiency of dietitians' work in the nutritional follow-up of patients with stage 4 or 5 chronic kidney disease?\n\nParticipants will:\n\nReceive a URIKI kit at home, including a portable reader, urine test strips, and access to the My URIKI mobile application.\n\nPerform one urine measurement per day at home for 10 consecutive days using the URIKI device.\n\nEnter nutrition- and health-related information into the application, including meal photographs or descriptions, hydration information, and responses to brief questionnaires.\n\nReceive remote support for installation and use of the device if needed. Have their urinary measurements reviewed by authorized healthcare professionals.\n\nReceive a personalized dietary assessment and nutritional feedback from the hospital medical team and\u002For IKI dietitians through the My URIKI application.\n\nComplete patient experience questionnaires at study entry and at the end of participation.\n\nThe expected duration of participation is up to 30 days. Approximately 450 patients with stage 4 or 5 chronic kidney disease will be enrolled in nephrology centers across France.",[84],"Chronic Kidney Disease (CKD)","NOT_YET_RECRUITING","2026-08-03",{"date":88,"type":89},"2026-08-04","ACTUAL",{"date":91,"type":78},"2026-10",{"date":93,"type":78},"2027-11",{"name":5,"class":6},2]