Non-invasive Testing for End-Stage Chronic Kidney Disease

NCT07777523 | Completed FDA Device

• 3 other identifiers: NiTED-GB-TrialAgreement 700-2845/20-000HSMLP2025/195
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PORTABLE TEST; POTASSIUM; CAPILLARY BLOOD; UREA; DIALYSIS; RENAL; ESCKD; DIGITAL; METHOD VALIDATION; MULTIPLEX; NONINVASIVE

Outcome Measures

Primary Outcomes (2)

• Agreement and correlation of urea concentrations measured in capillary blood using the KF4+ digital test and in venous blood using the reference laboratory method.

  Urea concentrations measured using the KF4+ digital test in capillary blood will be compared with urea concentrations measured using the reference laboratory method in venous blood samples. Agreement between the two methods will be assessed using Bland-Altman analysis, including Bland-Altman plots. Correlation between the two methods will be assessed using Spearman correlation analysis and linear regression. All analyses will be based on paired capillary and venous blood measurements.

  Immediately before and immediately after a routine dialysis session.

• Agreement and correlation of potassium concentrations measured in capillary blood using the KF4+ digital test and in venous blood using the reference laboratory method

  Potassium concentrations measured using the KF4+ digital test in capillary blood will be compared with potassium concentrations measured using the reference laboratory method in venous blood samples. Agreement between the two methods will be assessed using Bland-Altman analysis, including Bland-Altman plots. Correlation between the two methods will be assessed using Spearman correlation analysis and linear regression. All analyses will be based on paired capillary and venous blood measurements.

  Immediately before a routine dialysis session.

Secondary Outcomes (1)

• Agreement between Kt/V calculated from capillary blood urea and Kt/V calculated from venous blood urea.

  Kt/V is calculated immediately after a routine dialysis session using urea levels measured immediately before and immediately after the dialysis session.

Study Arms (1)

Adult patients with end-stage renal disease undergoing chronic dialysis

This is a prospective, single-center, observational diagnostic study conducted in adult patients with end-stage renal disease undergoing chronic dialysis from Hospital Interzonal General de Agudos General San Martín, La Plata, Argentina.

Diagnostic Test: KF4+ Noninvasive Test

Interventions

KF4+ Noninvasive Test DIAGNOSTIC_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.

Adult patients with end-stage renal disease undergoing chronic dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End-Stage Chronic Kidney Disease Patients under Chronic Dialysis from Hospital Interzonal General de Agudos General San Martín La Plata, Argentina

You may qualify if:

• Adult patients (≥18 years)
• Diagnosis of end-stage renal disease
• Receiving chronic dialysis treatment
• Receiving chronic hemodialysis treatment
• Able and willing to provide written informed consent

You may not qualify if:

• Inability to provide informed consent
• Any condition that, in the opinion of the investigator, would interfere with participation or data interpretation

Sponsors & Collaborators

• Gisens Biotech: lead
• Universidad Nacional de La Plata: collaborator
• Hospital Interzonal General de Agudos General San Martín: collaborator

Study Sites (1)

Hospital Interzonal General de Agudos General San Martín La Plata, Argentina

La Plata, Buenos Aires, 1900, Argentina

Location

Related Publications (4)

• Diforti, J.F., Cunningham, T., Zegalo, Z., Piccinini, E., Marmisollé, W.A., Piccinini, J.M. and Azzaroni, O., 2024. Transforming Renal Diagnosis: Graphene-Enhanced Lab-On-a-Chip for Multiplexed Kidney Biomarker Detection in Capillary Blood. Advanced Sensor Research, 3(11), p.2400061.

  BACKGROUND

• Murray JS, Williams CJ, Lendrem C, Smithson J, Allinson C, Robinson J, Walker A, Winter A, Simpson AJ, Newton J, Wroe C, Jones WS. Patient Self-Testing of Kidney Function at Home, a Prospective Clinical Feasibility Study in Kidney Transplant Recipients. Kidney Int Rep. 2023 Mar 28;8(6):1170-1182. doi: 10.1016/j.ekir.2023.03.003. eCollection 2023 Jun.

  PMID: 37284676 BACKGROUND

• Griva K, Nandakumar M, Ng JH, Lam KFY, McBain H, Newman SP. Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis. Am J Kidney Dis. 2018 Mar;71(3):371-381. doi: 10.1053/j.ajkd.2017.09.014. Epub 2017 Dec 1.

  PMID: 29198641 BACKGROUND

• Diforti JF, Cunningham T, Piccinini E, Marmisolle WA, Piccinini JM, Azzaroni O. Noninvasive and Multiplex Self-Test of Kidney Disease Biomarkers with Graphene-Based Lab-on-a-Chip (G-LOC): Toward Digital Diagnostics in the Hands of Patients. Anal Chem. 2024 Apr 16;96(15):5832-5842. doi: 10.1021/acs.analchem.3c05148. Epub 2024 Apr 4.

  PMID: 38573917 BACKGROUND

Related Links

• Gisens Biotech Website
• Hospital General San Martín Website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Uremia

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 Officials

• Esteban Piccinini, PhD

  Universidad Nacional de La Plata

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 20, 2026
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)