Chronic Kidney DiseasesNCT07251075
Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
An observational study of Chronic Kidney Diseases and Kidney Injury, Acute, run by Tingting Xu.
Trial summary
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Injury, Acute
- What is being tested?
- Reference Creatinine Test System（Cobas c 111） and Investigational Creatinine Test System （EG）
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Dec 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Include at least 80% patients with varying stages of non-dialysis dependent kidney disease, as well as a small group (e.g.<20 %) of healthy volunteers and dialysis-dependent kidney disease patients, to cover the reference interval of the creatinine concentration. All subjects should be naive to this creatinine monitoring system and the similar self-monitoring devices (including but not limited to glucose, ketone, total cholesterol, etc.).
Who may be able to join
- Abnormal creatinine levels or suspected kidney disease;
- Aged 18 and above, gender is not limited;
- Voluntarily participate in this clinical study by signing the informed consent form.
Who cannot join
- The HCT range is not within 25-65%;
- Severe mental illness or other conditions that make the patient unable to cooperate;
- Inability to read or write in English language;
- Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.);
- Previous experience with this creatinine monitoring system or similar self-monitoring devices (including but not limited to those for glucose, ketones, total cholesterol, etc.);
- Other conditions that, in the opinion of the investigator, make participation in this clinical trial inappropriate.
About this study
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with non-dialysis-dependent kidney disease.
The main questions it aims to answer are:
Read more
- How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method?
- How usable is the Creatinine Monitoring System for laypersons in a home setting?
Researchers will compare creatinine results obtained with the investigational creatinine test system (fingerstick capillary whole blood) to those from a Cobas biochemical analysis system（referred to as Cobas) (venous plasma) to determine whether the investigational device provides accurate and reliable measurements.
Participants will:
- Provide a venous blood sample for comparative testing.
- Perform self-testing using the Creatinine Monitoring System without prior training.
- Complete a usability questionnaire about their experience with the investigational creatinine test system.
Read the detailed description
This clinical performance study is designed to evaluate the accuracy and usability of the Creatinine Monitoring System under controlled conditions. Prior to study initiation, the investigational device, comparator device, and associated instruments will be verified to ensure calibration and proper function. All study personnel will undergo training on the protocol, informed consent procedures, and case report form (CRF) completion, and a kick-off meeting will be held to clarify roles and responsibilities.
Participants will be enrolled strictly according to the predefined inclusion and exclusion criteria. Each subject will be assigned blinded identification numbers, including subject numbers, tester numbers, and venous blood sample numbers, to minimize bias. Venous blood will be collected for hematocrit testing and comparator analysis. Following blood collection, layperson participants will receive the complete investigational device package, including the instructions for use (IFU) and relevant labeling, and will perform self-testing without any prior training or assistance. Self-testing will take place in a separate room to avoid influence from previous participants. Disinfection of the handheld electrochemical meter will be performed using CLOROX HEALTHCARE Bleach Germicidal Wipes as specified in the user manual.
After completing self-testing, layperson participants will assess the usability of the device by filling out a structured questionnaire, focusing on IFU readability and ease of use. In parallel, trained observers will complete an observer questionnaire to document any operational errors or deviations during the testing process.
Once all testing is complete, results will be unblinded. Study data will be collected and verified by the clinical research associate (CRA) for completeness and accuracy of the CRFs. Statistical analyses will then be performed by qualified statisticians on the finalized dataset, and findings will be summarized in a clinical performance study report.
Importantly, this study is observational in nature. The investigational and reference creatinine measurements are performed for research purposes only. Clinical diagnosis, treatment, and patient management are not affected by the investigational device results, and all medical care is provided according to routine clinical practice.
- Conditions
- Chronic Kidney Diseases, Kidney Injury, Acute
- Being tested
- Reference Creatinine Test System（Cobas c 111）, Investigational Creatinine Test System （EG）
- Keywords
- Creatinine, Chronic kidney diseases, Kidney Injury, acute, POCT, Eaglenos
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference Creatinine Test System（Cobas c 111）Diagnostic test
This group involves the use of the Cobas biochemical analyzer for measurement of venous plasma creatinine samples. The results obtained from Cobas will be compared with those obtained from the investigational Eaglenos Creatinine Test System to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.
Investigational Creatinine Test System （EG）Diagnostic test
This group involves the use of the Eaglenos Creatinine Test System, a handheld device designed for self-testing of fingerstick capillary whole blood by laypersons with non-dialysis-dependent kidney disease. The results obtained from EG will be compared with those obtained from the Cobas biochemical analyzer to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cobas Group | Blood creatinine measurements are performed using the Cobas biochemical analyzer with venous plasma. The results will be compared with those obtained from the investigational Eaglenos Creatinine Test System using fingerstick capillary whole blood. Receives: Diagnostic Test: Reference Creatinine Test System（Cobas c 111） | |
| Group 2: EG Group | Blood creatinine measurements are performed using the Eaglenos Creatinine Test System with fingerstick capillary whole blood. The results will be compared with those obtained from the Cobas biochemical analyzer using venous plasma. Receives: Diagnostic Test: Investigational Creatinine Test System （EG） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Concentrations Measured by the Eaglenos Creatinine Test System Compared With the Cobas c 111
Creatinine concentrations (mg/dL) will be measured in fingerstick capillary whole blood using the Eaglenos Creatinine Test System and in venous plasma using the Cobas c 111 analyzer. Agreement between the two systems will be assessed using Bland-Altman analysis.
Measured: Day 0 (at the time of blood sample collection).
Correlation of Creatinine Concentrations Between the Eaglenos Creatinine Test System and the Cobas c 111
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be assessed for linear correlation using Pearson's correlation coefficient (r).
Measured: Day 0 (at the time of blood sample collection).
Predicted Differences in Creatinine Concentrations at Predefined Medical Decision Levels Between the Eaglenos Creatinine Test System and the Cobas c 111
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be used to calculate predicted differences (predicted bias) at predefined medical decision levels using Passing-Bablok regression based on all paired measurements. These levels correspond to clinically relevant cut-off values for patient management.
Measured: Day 0 (at the time of blood sample collection).
Number of Outlier Measurements in Creatinine Concentration Between the Eaglenos Creatinine Test System and Cobas c 111
Outliers in paired creatinine measurements (mg/dL) from the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be identified using the Extreme Studentized Deviate (ESD) method. The frequency of outlier values will be reported.
Measured: Day 0 (at the time of blood sample collection).
System Usability Score of the Eaglenos Creatinine Test System by Laypersons
The overall usability of the Eaglenos Creatinine Test System will be evaluated using the System Usability Scale (SUS), a standardized questionnaire. SUS scores range from 10 (lowest usability) to 50 (highest usability), with higher scores indicating better usability. The distribution of participants across score segments will be reported.
Measured: Day 0 (at the time of blood sample collection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tingting Xu
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Tingting Xu, Eaglenos Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251075
- Sponsor's protocol ID
- BM15861
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected lPD
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
- ClinicalTrials.gov ID
- NCT07251075
- Acronym / sponsor ID
- BM15861
- Conditions
- Chronic Kidney Diseases, Kidney Injury, Acute
- Keywords
- Creatinine, Chronic kidney diseases, Kidney Injury, acute, POCT, Eaglenos
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tingting XuIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Nov 2025 (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 performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System（referred to as EG）, a point-of-care testing (POCT) system that consists of a handheld device and its associated creatinine test strips, intended for home use by laypersons with non-dialysis-dependent kidney disease.
The main questions it aims to answer are:
- How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method?
- How usable is the Creatinine Monitoring System for laypersons in a home setting?
Researchers will compare creatinine results obtained with the investigational creatinine test system (fingerstick capillary whole blood) to those from a Cobas biochemical analysis system（referred to as Cobas) (venous plasma) to determine whether the investigational device provides accurate and reliable measurements.
Participants will:
- Provide a venous blood sample for comparative testing.
- Perform self-testing using the Creatinine Monitoring System without prior training.
- Complete a usability questionnaire about their experience with the investigational creatinine test system.
Detailed description
This clinical performance study is designed to evaluate the accuracy and usability of the Creatinine Monitoring System under controlled conditions. Prior to study initiation, the investigational device, comparator device, and associated instruments will be verified to ensure calibration and proper function. All study personnel will undergo training on the protocol, informed consent procedures, and case report form (CRF) completion, and a kick-off meeting will be held to clarify roles and responsibilities.
Participants will be enrolled strictly according to the predefined inclusion and exclusion criteria. Each subject will be assigned blinded identification numbers, including subject numbers, tester numbers, and venous blood sample numbers, to minimize bias. Venous blood will be collected for hematocrit testing and comparator analysis. Following blood collection, layperson participants will receive the complete investigational device package, including the instructions for use (IFU) and relevant labeling, and will perform self-testing without any prior training or assistance. Self-testing will take place in a separate room to avoid influence from previous participants. Disinfection of the handheld electrochemical meter will be performed using CLOROX HEALTHCARE Bleach Germicidal Wipes as specified in the user manual.
After completing self-testing, layperson participants will assess the usability of the device by filling out a structured questionnaire, focusing on IFU readability and ease of use. In parallel, trained observers will complete an observer questionnaire to document any operational errors or deviations during the testing process.
Once all testing is complete, results will be unblinded. Study data will be collected and verified by the clinical research associate (CRA) for completeness and accuracy of the CRFs. Statistical analyses will then be performed by qualified statisticians on the finalized dataset, and findings will be summarized in a clinical performance study report.
Importantly, this study is observational in nature. The investigational and reference creatinine measurements are performed for research purposes only. Clinical diagnosis, treatment, and patient management are not affected by the investigational device results, and all medical care is provided according to routine clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cobas Group | – | Diagnostic Test: Reference Creatinine Test System（Cobas c 111）Blood creatinine measurements are performed using the Cobas biochemical analyzer with venous plasma. The results will be compared with those obtained from the investigational Eaglenos Creatinine Test System using fingerstick capillary whole blood. |
| Group 2: EG Group | – | Diagnostic Test: Investigational Creatinine Test System （EG）Blood creatinine measurements are performed using the Eaglenos Creatinine Test System with fingerstick capillary whole blood. The results will be compared with those obtained from the Cobas biochemical analyzer using venous plasma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Include at least 80% patients with varying stages of non-dialysis dependent kidney disease, as well as a small group (e.g.<20 %) of healthy volunteers and dialysis-dependent kidney disease patients, to cover the reference interval of the creatinine concentration. All subjects should be naive to this creatinine monitoring system and the similar self-monitoring devices (including but not limited to glucose, ketone, total cholesterol, etc.).
Key inclusion criteria (3 listed)
- Abnormal creatinine levels or suspected kidney disease;
- Aged 18 and above, gender is not limited;
- Voluntarily participate in this clinical study by signing the informed consent form.
Key exclusion criteria (6 listed)
- The HCT range is not within 25-65%;
- Severe mental illness or other conditions that make the patient unable to cooperate;
- Inability to read or write in English language;
- Incomplete subject information (including but not limited to gender, age, education level, clinical diagnosis information; etc.);
- Previous experience with this creatinine monitoring system or similar self-monitoring devices (including but not limited to those for glucose, ketones, total cholesterol, etc.);
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 |
|---|---|---|
| Reference Creatinine Test System（Cobas c 111）This group involves the use of the Cobas biochemical analyzer for measurement of venous plasma creatinine samples. The results obtained from Cobas will be compared with those obtained from the investigational Eaglenos Creatinine Test System to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements. | Diagnostic test | Group 1: Cobas Group |
| Investigational Creatinine Test System （EG）This group involves the use of the Eaglenos Creatinine Test System, a handheld device designed for self-testing of fingerstick capillary whole blood by laypersons with non-dialysis-dependent kidney disease. The results obtained from EG will be compared with those obtained from the Cobas biochemical analyzer to evaluate the accuracy and reliability of the investigational device. Study participant management and clinical care will not be influenced by the results of these study measurements. | Diagnostic test | Group 2: EG Group |
Primary outcome
Creatinine Concentrations Measured by the Eaglenos Creatinine Test System Compared With the Cobas c 111
Time frame: Day 0 (at the time of blood sample collection).
Creatinine concentrations (mg/dL) will be measured in fingerstick capillary whole blood using the Eaglenos Creatinine Test System and in venous plasma using the Cobas c 111 analyzer. Agreement between the two systems will be assessed using Bland-Altman analysis.
Correlation of Creatinine Concentrations Between the Eaglenos Creatinine Test System and the Cobas c 111
Time frame: Day 0 (at the time of blood sample collection).
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be assessed for linear correlation using Pearson's correlation coefficient (r).
Predicted Differences in Creatinine Concentrations at Predefined Medical Decision Levels Between the Eaglenos Creatinine Test System and the Cobas c 111
Time frame: Day 0 (at the time of blood sample collection).
Creatinine concentrations (mg/dL) measured by the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be used to calculate predicted differences (predicted bias) at predefined medical decision levels using Passing-Bablok regression based on all paired measurements. These levels correspond to clinically relevant cut-off values for patient management.
Number of Outlier Measurements in Creatinine Concentration Between the Eaglenos Creatinine Test System and Cobas c 111
Time frame: Day 0 (at the time of blood sample collection).
Outliers in paired creatinine measurements (mg/dL) from the Eaglenos Creatinine Test System (capillary whole blood) and the Cobas c 111 analyzer (venous plasma) will be identified using the Extreme Studentized Deviate (ESD) method. The frequency of outlier values will be reported.
System Usability Score of the Eaglenos Creatinine Test System by Laypersons
Time frame: Day 0 (at the time of blood sample collection).
The overall usability of the Eaglenos Creatinine Test System will be evaluated using the System Usability Scale (SUS), a standardized questionnaire. SUS scores range from 10 (lowest usability) to 50 (highest usability), with higher scores indicating better usability. The distribution of participants across score segments will be reported.
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 26 Nov 2025.
- Individual participant dataSharing planned: Yes. All collected lPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Kidney Injury, Acute, run by Tingting Xu.
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 3 inclusion and 6 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine Concentrations Measured by the Eaglenos Creatinine Test System Compared With the Cobas c 111 (time frame: Day 0 (at the time of blood sample collection).). The study lists 5 primary outcomes in all. 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 26 Nov 2025.