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NCT Number: 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

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.

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Key information

Conditions

Chronic Kidney Disease (CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

URIKI Digital Urinary Monitoring System

Device

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.

Other names: My URIKI

Primary outcomes

  1. Before-after mean duration of dietitian consultations

    Time frame: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system

    Difference in the mean duration of dietitian consultations dedicated to nutritional assessment per patient, comparing the pre-intervention period (conventional care) and the post-intervention period (care integrating URIKI).

Secondary outcomes

  1. Carbon footprint of the care pathway

    Time frame: Up to 12 months

    Estimated change in the carbon footprint of the CKD nutritional care pathway before and after URIKI implementation.

  2. Renal outcome

    Time frame: Up to 12 months

    Change in estimated glomerular filtration rate (eGFR) slope.

  3. Biological outcome

    Time frame: Up to 12 months

    Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria.

  4. Patient satisfaction

    Time frame: Around Day 30 following URIKI use

    Patient satisfaction score

  5. Patient engagement

    Time frame: Around Day 30 following URIKI use

    Therapeutic education program adherence score

  6. Patient digital acceptability

    Time frame: Around Day 30 following URIKI use

    Digital solution acceptability score

  7. Healthcare professional quality of working life

    Time frame: Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).

    Quality of working life (QWL) score among healthcare professionals, particularly dietitians.

Study contacts

Contact information is provided by the study sponsor or research team.

Youcef Sekour

CONTACT

[email protected]

+33156095823

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • SKEZI, IKI, DALI

Registry information

Acronym: URIKI-MRC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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