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Non-invasive Testing for End-Stage Chronic Kidney Disease
Sponsor: Gisens Biotech
Summary
This study evaluates the clinical performance of a non-invasive digital diagnostic test (KF4+, developed and manufactured by Gisens Biotech) for the measurement of urea and potassium in capillary blood in patients with end-stage renal disease (ESRD) undergoing dialysis. Measurements obtained using the KF4+ test in capillary blood are compared with hospital laboratory reference methods performed on venous blood samples. The study also assesses the feasibility of determining dialysis efficiency, expressed as Kt/V, using non-invasive samples. The objective is to determine agreement, correlation, and clinical comparability between methods, and to evaluate the use of capillary blood as an alternative to venous sampling in routine dialysis monitoring.
Official title: Noninvasive, Multiplex and Portable Testing of Urea and Potassium to Enable Patient-Centered Monitoring of End-Stage Chronic Kidney Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
55
Start Date
2025-10-01
Completion Date
2025-12-31
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
KF4+ Noninvasive Test
This is an observational clinical study. The KF4+ is a portable and digital test used to measure urea and potassium concentrations in capillary blood samples. Results are compared with hospital laboratory reference methods performed on venous blood. The KF4+ test is used for measurement only and does not influence clinical management or dialysis prescription.
Locations (1)
Hospital Interzonal General de Agudos General San Martín La Plata, Argentina
La Plata, Buenos Aires, Argentina