Renal Disease, ChronicNiTEDNCT07777523
Non-invasive Testing for End-Stage Chronic Kidney Disease
An observational study of Renal Disease, Chronic and Renal Disease, End-Stage, run by Gisens Biotech at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease, Chronic, Renal Disease, End-Stage, Dialysis Patients
- What is being tested?
- KF4+ Noninvasive Test
- How many people
- 55 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2025to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-Stage Chronic Kidney Disease Patients under Chronic Dialysis from Hospital Interzonal General de Agudos General San Martín La Plata, Argentina
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Any condition that, in the opinion of the investigator, would interfere with participation or data interpretation
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Interzonal General de Agudos General San Martín La Plata, Argentina
La Plata, Buenos Aires, 1900
About this study
Official title: Noninvasive, Multiplex and Portable Testing of Urea and Potassium to Enable Patient-Centered Monitoring of End-Stage Chronic Kidney Disease
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.
Read the detailed description
The adequacy of dialysis treatment is traditionally assessed by measuring serum urea and calculating Kt/V, which requires venous blood sampling and laboratory infrastructure. This observational diagnostic study evaluates the use of a portable, bioelectronic point-of-care test (KF4+, Gisens Biotech) for measuring urea and potassium in capillary blood as a non-invasive alternative. KF4+ test is a disposable cartridge based on electrochemical detection of analytes inside.
Adult patients with end-stage renal disease undergoing chronic hemodialysis from Hospital Interzonal General de Agudos "General San Martín" are enrolled. Capillary blood samples are collected before and after dialysis sessions and analyzed using the KF4+ digital test. Venous blood samples collected at the same time points are analyzed using standard hospital laboratory reference methods with the autoanalyzer Wiener Lab CMD 800i. Method comparison analyses are performed to evaluate agreement and correlation between capillary and venous measurements.
Dialysis efficiency is assessed by calculating Kt/V using urea values obtained from capillary blood and comparing these results with Kt/V calculated from venous blood measurements. The study is conducted at a single hospital center and follows a paired, comparative, observational design. KF4+ results were not used for clinical decision-making.
- Conditions
- Renal Disease, Chronic, Renal Disease, End-Stage, Dialysis Patients, Urea in Blood; High, Potassium Measurement, Noninvasive
- Being tested
- KF4+ Noninvasive Test
- Keywords
- PORTABLE TEST, POTASSIUM, CAPILLARY BLOOD, UREA, DIALYSIS, RENAL, ESCKD, DIGITAL, METHOD VALIDATION, MULTIPLEX, NONINVASIVE
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KF4+ Noninvasive TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: KF4+ Noninvasive Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Agreement between Kt/V calculated using urea concentrations measured in capillary blood with the KF4+ test and Kt/V calculated using urea concentrations measured in venous blood using the reference laboratory method. Agreement between the two methods will be assessed using paired statistical tests. Kt/V will be calculated using the single pool Kt/V equation as indicated by KDIGO 2024 clinical guideline.
Measured: Kt/V is calculated immediately after a routine dialysis session using urea levels measured immediately before and immediately after the dialysis session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Disease, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gisens Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional de La Plata, Hospital Interzonal General de Agudos General San Martín
- Responsible party
- Sponsor
- Investigators
- Esteban Piccinini, PhD, Study director, Universidad Nacional de La Plata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777523
- Sponsor's protocol ID
- NiTED-GB-Trial
- Other IDs
- Agreement 700-2845/20-000, HSMLP2025/195
- Acronym
- NiTED
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to participant privacy and confidentiality considerations. Only aggregated study results will be reported and shared.
Publications
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.
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.
PubMed 37284676Griva 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.
PubMed 29198641Diforti 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.
PubMed 38573917
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive, Multiplex and Portable Testing of Urea and Potassium to Enable Patient-Centered Monitoring of End-Stage Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07777523
- Acronym / sponsor ID
- NiTED / NiTED-GB-Trial
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Gisens BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Nacional de La Plata, Hospital Interzonal General de Agudos General San Martín
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The adequacy of dialysis treatment is traditionally assessed by measuring serum urea and calculating Kt/V, which requires venous blood sampling and laboratory infrastructure. This observational diagnostic study evaluates the use of a portable, bioelectronic point-of-care test (KF4+, Gisens Biotech) for measuring urea and potassium in capillary blood as a non-invasive alternative. KF4+ test is a disposable cartridge based on electrochemical detection of analytes inside.
Adult patients with end-stage renal disease undergoing chronic hemodialysis from Hospital Interzonal General de Agudos "General San Martín" are enrolled. Capillary blood samples are collected before and after dialysis sessions and analyzed using the KF4+ digital test. Venous blood samples collected at the same time points are analyzed using standard hospital laboratory reference methods with the autoanalyzer Wiener Lab CMD 800i. Method comparison analyses are performed to evaluate agreement and correlation between capillary and venous measurements.
Dialysis efficiency is assessed by calculating Kt/V using urea values obtained from capillary blood and comparing these results with Kt/V calculated from venous blood measurements. The study is conducted at a single hospital center and follows a paired, comparative, observational design. KF4+ results were not used for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with end-stage renal disease undergoing chronic dialysis | – | Diagnostic Test: KF4+ Noninvasive TestThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-Stage Chronic Kidney Disease Patients under Chronic Dialysis from Hospital Interzonal General de Agudos General San Martín La Plata, Argentina
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Any condition that, in the opinion of the investigator, would interfere with participation or data interpretation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KF4+ Noninvasive TestThis 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. | Diagnostic test | Adult patients with end-stage renal disease undergoing chronic dialysis |
Primary outcome
Agreement and correlation of urea concentrations measured in capillary blood using the KF4+ digital test and in venous blood using the reference laboratory method.
Time frame: Immediately before and immediately after a routine dialysis session.
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.
Agreement and correlation of potassium concentrations measured in capillary blood using the KF4+ digital test and in venous blood using the reference laboratory method
Time frame: Immediately before a routine dialysis session.
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.
1 secondary outcome
Agreement between Kt/V calculated from capillary blood urea and Kt/V calculated from venous blood urea.
Time frame: Kt/V is calculated immediately after a routine dialysis session using urea levels measured immediately before and immediately after the dialysis session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- BackgroundDiforti, 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: PubMed 37284676Murray 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.
- Background: PubMed 29198641Griva 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.
- Background: PubMed 38573917Diforti 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.
- Gisens Biotech WebsiteLink provided by the sponsor.
- Hospital General San Martín WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to participant privacy and confidentiality considerations. Only aggregated study results will be reported and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban Piccinini, PhD study director
Universidad Nacional de La Plata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, Chronic and Renal Disease, End-Stage, run by Gisens Biotech at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement and correlation of urea concentrations measured in capillary blood using the KF4+ digital test and in venous blood using the reference laboratory method. (time frame: Immediately before and immediately after a routine dialysis session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777523, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.