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

Обзор

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.

Вмешательства

• Устройство 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-repo

Первичные конечные точки

• Before-after mean duration of dietitian consultations [Срок оценки: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system]

Вторичные конечные точки (7)

• Carbon footprint of the care pathway [Срок оценки: Up to 12 months]
• Renal outcome [Срок оценки: Up to 12 months]
• Biological outcome [Срок оценки: Up to 12 months]
• Patient satisfaction [Срок оценки: Around Day 30 following URIKI use]
• Patient engagement [Срок оценки: Around Day 30 following URIKI use]
• Patient digital acceptability [Срок оценки: Around Day 30 following URIKI use]
• Healthcare professional quality of working life [Срок оценки: Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 2 центра

• Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et O — Paris
• Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrolo — Paris

Идентификаторы

NCT: NCT07746037 · APHP260533 · 2026-A00977-44

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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