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NCT07777523 · ClinicalTrials.gov record · last posted 2026-08-20

Non-invasive Testing for End-Stage Chronic Kidney Disease

Study acronym: NiTED
StatusCompleted
PhaseNot specified
Started2025-10-01
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07777523
Lead Sponsor Gisens Biotech
Collaborators: Universidad Nacional de La Plata, Hospital Interzonal General de Agudos General San Martín
Conditions Renal Disease, Chronic, Renal Disease, End-Stage, Dialysis Patients, Urea in Blood; High, Potassium Measurement, Noninvasive
Enrollment 55 participants
Start Date 2025-10-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-20