Non-invasive Testing for End-Stage Chronic Kidney Disease

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Participants enrolled: 55
• From 1 Oct 2025 to the primary completion date, 31 Dec 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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