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)
2026년 8월 3일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
450
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Youcef Sekour
- 전화번호: +33156095823
- 이메일: youcef.sekour@aphp.fr
연구 장소
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Paris, 프랑스
- Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
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연락하다:
- Corinne Isnard Bagnis
- 전화번호: 0033142177211
- 이메일: corinne.bagnis@aphp.fr
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수석 연구원:
- Corinne Isnard Bagnis
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Paris, 프랑스
- Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
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수석 연구원:
- Jean-Jacques Boffa
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연락하다:
- Jean-Jacques Boffa
- 전화번호: 0033156016029
- 이메일: jean-jacques.boffa@aphp.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Before-after mean duration of dietitian consultations
기간: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system
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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).
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Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Carbon footprint of the care pathway
기간: Up to 12 months
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Estimated change in the carbon footprint of the CKD nutritional care pathway before and after URIKI implementation.
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Up to 12 months
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Renal outcome
기간: Up to 12 months
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Change in estimated glomerular filtration rate (eGFR) slope.
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Up to 12 months
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Biological outcome
기간: Up to 12 months
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Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria.
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Up to 12 months
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Patient satisfaction
기간: Around Day 30 following URIKI use
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Patient satisfaction score
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Around Day 30 following URIKI use
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Patient engagement
기간: Around Day 30 following URIKI use
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Therapeutic education program adherence score
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Around Day 30 following URIKI use
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Patient digital acceptability
기간: Around Day 30 following URIKI use
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Digital solution acceptability score
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Around Day 30 following URIKI use
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Healthcare professional quality of working life
기간: Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).
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Quality of working life (QWL) score among healthcare professionals, particularly dietitians.
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Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Corinne Isnard Bagnis, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2027년 11월 1일
연구 완료 (추정된)
2027년 11월 1일
연구 등록 날짜
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
2026년 8월 3일
처음 게시됨 (실제)
2026년 8월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 3일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP260533
- 2026-A00977-44 (기타 식별자: ANSM (French National Agency for the Safety of Medicines and Health Products))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Two years after the last publication
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .