A home urine test strip to support diet monitoring in advanced kidney disease
Tests a connected urine strip for diet follow-up in people with advanced chronic kidney disease.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the 2 sites
- Trial code
- Registry title
- 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
- Status
- Not yet recruiting
- People taking part
- 450 people, planned
- Started
- Oct 2026
- Expected to end
- Nov 2027
- Type of study
- Interventional
- Treatments tested
- URIKI Digital Urinary Monitoring System
- Record updated
- 4 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage 4 or 5 chronic kidney disease who are followed in a nephrology department and need a nutritional assessment. They test their urine at home for 10 days with a connected strip reader.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Chronic kidney disease stage 4 or 5, with eGFR <30 mL/min/1.73 m²
Main reasons for not taking part
- Pregnant or breastfeeding women
- Severe memory or thinking problems that prevent following the study or using the app without a caregiver
- Major movement or sensory problems (for example blindness) that prevent using the device without a caregiver
- Cannot understand French or English without help from another person
- Taking part in another interventional study that does not fit with this one
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Severe cognitive impairment preventing understanding of study procedures or use of the application without caregiver assistance
- Pregnant or breastfeeding women
- 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
- Individuals under legal protection (guardianship or curatorship), unless participation is authorized by the legal representative and ethics committee
Where in France
- Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-NéphrologieParis, FranceContact: Corinne Isnard BagnisNo longer taking part
- Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-NéphrologieParis, FranceContact: Jean-Jacques BoffaNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- single armTreatment being tested
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.
Treatment: URIKI Digital Urinary Monitoring System
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- A home urine test strip to support diet monitoring in advanced kidney diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 4 August 2026