Assessment of Dietary Balance in Home-Dwelling Patients With Stage 4 and 5 Chronic Kidney Disease… (NCT07746037) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
France450 participantsStarted 2026-10
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Before-after mean duration of dietitian consultations
Timeframe: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system