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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)

3 augustus 2026 bijgewerkt door: Assistance Publique - Hôpitaux de Paris

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

450

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Frankrijk
      • Paris, Frankrijk
        • Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
        • Contact:
        • Hoofdonderzoeker:
          • Corinne Isnard Bagnis
      • Paris, Frankrijk
        • Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
        • Hoofdonderzoeker:
          • Jean-Jacques Boffa
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Andere namen:
  • My URIKI

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Before-after mean duration of dietitian consultations
Tijdsspanne: 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).
Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Assistance Publique - Hôpitaux de Paris

Medewerkers

SKEZI, IKI, DALI

Onderzoekers

  • Hoofdonderzoeker: Corinne Isnard Bagnis, Assistance Publique - Hôpitaux de Paris

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 november 2027

Studie voltooiing (Geschat)

1 november 2027

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2026

Eerst geplaatst (Werkelijk)

4 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APHP260533
  • 2026-A00977-44 (Andere identificatie: ANSM (French National Agency for the Safety of Medicines and Health Products))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Two years after the last publication

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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