Chronic Kidney Disease (CKD)URIKI-MRCNCT07746037
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
A study testing URIKI Digital Urinary Monitoring System in people with Chronic Kidney Disease (CKD), run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- URIKI Digital Urinary Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hôpital Pitié-Salpêtrière - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
Paris
Corinne Isnard Bagnis, 0033142177211, corinne.bagnis@aphp.fr
Corinne Isnard Bagnis
Hôpital Tenon - APHP, Département de Néphrologie, Néphrologie Ambulatoire et Onco-Néphrologie
Paris
Jean-Jacques Boffa, 0033156016029, jean-jacques.boffa@aphp.fr
Jean-Jacques Boffa
About this study
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:
Read more
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.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- URIKI Digital Urinary Monitoring System
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URIKI Digital Urinary Monitoring SystemDevice
Also called My URIKI
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | 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. Receives: Device: URIKI Digital Urinary Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system
Secondary outcomes (7)
Carbon footprint of the care pathway
Estimated change in the carbon footprint of the CKD nutritional care pathway before and after URIKI implementation.
Measured: Up to 12 months
Renal outcome
Change in estimated glomerular filtration rate (eGFR) slope.
Measured: Up to 12 months
Biological outcome
Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria.
Measured: Up to 12 months
Patient satisfaction
Patient satisfaction score
Measured: Around Day 30 following URIKI use
Patient engagement
Therapeutic education program adherence score
Measured: Around Day 30 following URIKI use
Patient digital acceptability
Digital solution acceptability score
Measured: Around Day 30 following URIKI use
Healthcare professional quality of working life
Quality of working life (QWL) score among healthcare professionals, particularly dietitians.
Measured: Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- SKEZI, IKI, DALI
- Responsible party
- Sponsor
- Investigators
- Corinne Isnard Bagnis, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746037
- Sponsor's protocol ID
- APHP260533
- Other IDs
- 2026-A00977-44
- Acronym
- URIKI-MRC
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07746037
- Acronym / sponsor ID
- URIKI-MRC / APHP260533
- Conditions
- Chronic Kidney Disease (CKD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- SKEZI, IKI, DALI
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: URIKI Digital Urinary Monitoring SystemThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URIKI Digital Urinary Monitoring SystemAlso: My URIKIURIKI 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. | Device | single arm |
Primary outcome
Before-after mean duration of dietitian consultations
Time frame: 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).
7 secondary outcomes
Carbon footprint of the care pathway
Time frame: Up to 12 months
Renal outcome
Time frame: Up to 12 months
Biological outcome
Time frame: Up to 12 months
Patient satisfaction
Time frame: Around Day 30 following URIKI use
Patient engagement
Time frame: Around Day 30 following URIKI use
Patient digital acceptability
Time frame: Around Day 30 following URIKI use
Healthcare professional quality of working life
Time frame: Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Chronic Kidney Disease (CKD)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corinne Isnard Bagnis principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing URIKI Digital Urinary Monitoring System in people with Chronic Kidney Disease (CKD), run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youcef Sekour (+33156095823, youcef.sekour@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Before-after mean duration of dietitian consultations (time frame: Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.