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Non-invasive Testing for End-Stage Chronic Kidney Disease

NCT07777523 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Renal Disease, Chronic
  • Renal Disease, End-Stage
  • Dialysis Patients
  • Urea in Blood; High
  • Potassium Measurement
  • Noninvasive

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Universidad Nacional de La Plata

    collaborator OTHER

  • Hospital Interzonal General de Agudos General San Martín

    collaborator UNKNOWN

  • Gisens Biotech

    lead INDUSTRY

Principal Investigators

  • Esteban Piccinini, PhD · Universidad Nacional de La Plata

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777523 on ClinicalTrials.gov