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

Starting soon · Not applicable

Conditions studied: Chronic Kidney Disease (CKD)

In brief

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. The main question it aims to answer is: Does 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? Participants will: Receive a URIKI kit at home, including a portable reader, urine test strips, and access to the My URIKI mobile application. Perform one urine measurement per day at home for 10 consecutive days using the URIKI device. Enter nutrition- and health-related information into the application, including meal photographs or descriptions, hydration information, and responses to brief questionnaires. Receive remote support for installation and use of the device if needed. Have their urinary measurements reviewed by authorized healthcare professionals. Receive a personalized dietary assessment and nutritional feedback from the hospital medical team and/or IKI dietitians through the My URIKI application. Complete patient experience questionnaires at study entry and at the end of participation. The 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.

Key facts

Study ID: NCT07746037
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 450
Starts: 2026-10-01
Expected to finish: 2027-11-01
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults aged 18 years or older.
Chronic kidney disease (CKD) stage 4 or 5 with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
Followed in a nephrology department within a structured care pathway that includes nutritional assessment.
Clinical indication or need for nutritional assessment as part of routine care.
Willing and able to use the URIKI device for nutritional assessment.
Able to understand French or English, or assisted by a caregiver capable of supporting device use and understanding study procedures.
Agreement to the use of the device and to the collection and transmission of study-related data.
Affiliation with a social security system or beneficiary of such coverage.
Access to a compatible smartphone, a smartphone provided by IKI, or assistance from a caregiver for use of the mobile application

You may not qualify if…

Pregnant or breastfeeding women.
Severe cognitive impairment preventing understanding of study procedures or use of the application without caregiver assistance.
Major motor or sensory impairments (e.g., blindness, hemiplegia) preventing use of the device without caregiver assistance.
Inability to understand French or English without support from a caregiver or third party.
Refusal of the loaned smartphone or persistent inability to use the provided equipment despite support.
Refusal to participate in the study or withdrawal after receiving study information.
Concurrent participation in another interventional clinical study deemed incompatible with this study, or an ongoing exclusion period related to another study.
Individuals under legal protection (guardianship or curatorship), unless participation is authorized by the legal representative and ethics committee

Where it is running

Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie — Paris, France
Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie — Paris, France

Full record on ClinicalTrials.gov

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