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 (URIKI-MRC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease (CKD)
• Intervention / Treatment: Device: URIKI Digital Urinary Monitoring System

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youcef Sekour; Phone Number: +33156095823; Email: youcef.sekour@aphp.fr

Study Locations

• France
  • Paris, France
    • Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
    • Contact: Corinne Isnard Bagnis; Phone Number: 0033142177211; Email: corinne.bagnis@aphp.fr
    • Principal Investigator: Corinne Isnard Bagnis
  • Paris, France
    • Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
    • Principal Investigator: Jean-Jacques Boffa
    • Contact: Jean-Jacques Boffa; Phone Number: 0033156016029; Email: jean-jacques.boffa@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: single arm; 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.

Device: 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-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Before-after mean duration of dietitian consultations	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).	Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon footprint of the care pathway	Estimated change in the carbon footprint of the CKD nutritional care pathway before and after URIKI implementation.	Up to 12 months
Renal outcome	Change in estimated glomerular filtration rate (eGFR) slope.	Up to 12 months
Biological outcome	Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria.	Up to 12 months
Patient satisfaction	Patient satisfaction score	Around Day 30 following URIKI use
Patient engagement	Therapeutic education program adherence score	Around Day 30 following URIKI use
Patient digital acceptability	Digital solution acceptability score	Around Day 30 following URIKI use
Healthcare professional quality of working life	Quality of working life (QWL) score among healthcare professionals, particularly dietitians.	Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: SKEZI, IKI, DALI
• Investigators: Principal Investigator: Corinne Isnard Bagnis, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: August 3, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: APHP260533; 2026-A00977-44 (Other Identifier: ANSM (French National Agency for the Safety of Medicines and Health Products))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No