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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 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

450

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • França
      • Paris, França
        • Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
        • Contato:
        • Investigador principal:
          • Corinne Isnard Bagnis
      • Paris, França
        • Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
        • Investigador principal:
          • Jean-Jacques Boffa
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Dispositivo: 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.
Outros nomes:
  • My URIKI

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Before-after mean duration of dietitian consultations
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Carbon footprint of the care pathway
Prazo: 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
Prazo: Up to 12 months
Change in estimated glomerular filtration rate (eGFR) slope.
Up to 12 months
Biological outcome
Prazo: Up to 12 months
Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria.
Up to 12 months
Patient satisfaction
Prazo: Around Day 30 following URIKI use
Patient satisfaction score
Around Day 30 following URIKI use
Patient engagement
Prazo: Around Day 30 following URIKI use
Therapeutic education program adherence score
Around Day 30 following URIKI use
Patient digital acceptability
Prazo: Around Day 30 following URIKI use
Digital solution acceptability score
Around Day 30 following URIKI use
Healthcare professional quality of working life
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Assistance Publique - Hôpitaux de Paris

Colaboradores

SKEZI, IKI, DALI

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de novembro de 2027

Conclusão do estudo (Estimado)

1 de novembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

27 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de agosto de 2026

Primeira postagem (Real)

4 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Prazo de Compartilhamento de IPD

Two years after the last publication

Critérios de acesso de compartilhamento IPD

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).

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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