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)
2026年8月3日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
450
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Youcef Sekour
- 電話番号：+33156095823
- メール：youcef.sekour@aphp.fr
研究場所
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Paris、フランス
- Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
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コンタクト：
- Corinne Isnard Bagnis
- 電話番号：0033142177211
- メール：corinne.bagnis@aphp.fr
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主任研究者：
- Corinne Isnard Bagnis
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Paris、フランス
- Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
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主任研究者：
- Jean-Jacques Boffa
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コンタクト：
- Jean-Jacques Boffa
- 電話番号：0033156016029
- メール：jean-jacques.boffa@aphp.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Before-after mean duration of dietitian consultations
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Carbon footprint of the care pathway
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Corinne Isnard Bagnis、Assistance Publique - Hôpitaux de Paris
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年11月1日
研究の完了 (推定)
2027年11月1日
試験登録日
最初に提出
2026年7月27日
QC基準を満たした最初の提出物
2026年8月3日
最初の投稿 (実際)
2026年8月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月4日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- APHP260533
- 2026-A00977-44 (その他の識別子：ANSM (French National Agency for the Safety of Medicines and Health Products))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Two years after the last publication
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。