Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease

NCT07251075 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: BM15861
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 non-dialysis-dependent kidney disease. The main questions it aims to answer are:

1. 1.How consistent are creatinine measurements from the investigational creatinine test system compared with the clinical standard method?
2. 2.How usable is the Creatinine Monitoring System for laypersons in a home setting?
3. 3.Provide a venous blood sample for comparative testing.
4. 4.Perform self-testing using the Creatinine Monitoring System without prior training.
5. 5.Complete a usability questionnaire about their experience with the investigational creatinine test system.

Conditions

Chronic Kidney Diseases; Kidney Injury, Acute

Keywords

Creatinine; Chronic kidney diseases; Kidney Injury, acute; POCT; Eaglenos

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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.

  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.

  Day 0 (at the time of blood sample collection).

Study Arms (2)

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.

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.

Diagnostic Test: Investigational Creatinine Test System （EG）

Interventions

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.

Group 1: Cobas Group

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.

Group 2: EG Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tingting Xu: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biospecimen Description: Venous blood samples from non-dialysis-dependent kidney disease participants and healthy volunteers will be collected for comparative testing of creatinine levels using the Cobas biochemical analyzer. In addition, participants will perform self-testing using the investigational Creatinine Monitoring System with fresh finger capillary whole blood. No DNA or other genetic material will be extracted from any samples, and all samples will be retained only for the purpose of this study.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Affair Supervisor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 26, 2025
• Study Start: November 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Data will be made available to qualified researchers upon submission of a research proposal and executionof a data use agreement. Data access will be granted after the final study results are published and after anethical review by the institution's ethics board. Data sharing will be coordinated via email. Qualifiedresearchers can contact xu\ tingting@eaglenos.com to request access to the data.