Chronic Kidney Disease (CKD)KERMITNCT07047664
KERMIT: Sweat Patch for Early Kidney Disease Detection
A study testing KERMIT dermal patch in people with Chronic Kidney Disease (CKD), run by University of Ioannina.
Trial summary
Chronic kidney disease (CKD) affects over 10% of the global population, leading to significant morbidity, mortality, and economic burden. Early detection is crucial for preventing disease progression and complications; however, awareness and diagnosis of CKD remain alarmingly low. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- KERMIT dermal patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults aged ≥18 years with stable CKD, defined as:
- eGFR < 60 mL/min/1.73 m², or
- eGFR ≥ 60 mL/min/1.73 m² with documented evidence of kidney damage (persistent albuminuria, structural abnormalities on imaging or histology, or genetic kidney disease).
Who cannot join
- Any signs of dermal infections, open wounds, or skin irritation.
- Significant variations in eGFR in the last two months, defined as any absolute change (either increase or decline) in eGFR of >10 mL/min/1.73m2 ;
- Patients with a functioning kidney graft;
- Patients receiving immunosuppression treatment;
- Patients with kidney stones;
- Patients with uncontrolled hypertension (a systolic blood pressure (SBP) >150 mmHg and/or diastolic blood pressure (DBP) >90 mmHg with measurements taken under standardized conditions (e.g after a 5-minute seated rest, using validated equipment);
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- Patients receiving drugs reported to affect serum levels of creatinine and cystatin-c without affecting kidney function (i.e. cimetidine, trimethoprim, and fibrates);
- Known allergy to pilocarpine,
- Glaucoma;
- Patients with metal implants;
- Pregnancy;
- Active malignancy;
- Low life expectancy (<6 months) according to investigators judgement
About this study
Official title: Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring
Chronic kidney disease (CKD) affects over 10% of the global population, leading to significant morbidity, mortality, and economic burden. Early detection is crucial for preventing disease progression and complications; however, awareness and diagnosis of CKD remain alarmingly low. Current methods rely on blood or urine analysis, which are invasive and require specialized facilities. The KERMIT patch aims to address this gap by providing a wearable lab-on-a-chip device capable of measuring key biomarkers from sweat non-invasively. This innovation has the potential to revolutionize CKD diagnosis, particularly in remote or underserved areas.
The KERMIT patch integrates functional printed biosensors, a high-frequency electrochemical microchip, and a sustainable microfluidic system. Sensors are fabricated using carbon inks and 2D materials, enabling immunodetection and non-enzymatic sensing of creatinine, urea, and cystatin C. Preliminary tests evaluated detection limits, skin compatibility, and carbon footprint.
- Conditions
- Chronic Kidney Disease (CKD)
- Being tested
- KERMIT dermal patch
- Keywords
- CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KERMIT dermal patchDevice
The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function.
KERMIT dermal patchDevice
The KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function.
| Study group | Role | What they receive |
|---|---|---|
| CKD with eGFR < 60 mL/min/1.73 m² | Other | CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²), and Receives: Device: KERMIT dermal patch |
| CKD with eGFR ≥ 60 mL/min/1.73 m²) | Other | CKD patients with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m²) but with documented evidence of kidney damage (e.g., albuminuria, structural or genetic abnormalities). Receives: Device: KERMIT dermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine concentration in sweat
Estimate the concentration of creatinine in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage).
Unit of Measure: µmol/L
Measured: Day 1 (includes screening, device application, and sample analysis)
Urea concentration in sweat
Estimate the concentration of urea in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage).
Unit of Measure: mmol/L
Measured: Day 1 (includes screening, device application, and sample analysis)
Incidence of adverse events related to the wearable device
Assess the number and severity of adverse events related to the use of the wearable sweat-sensing device, including skin irritation, discomfort, or allergic reactions.
Unit of Measure: Number of events, graded by severity (mild, moderate, severe)
Measured: Day 1 (up to 1 hour post-device removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, parallel assignment interventional study designed to evaluate the diagnostic performance and safety of an experimental wearable sweat-sensing device. The study includes two parallel arms based on kidney function: * one arm of patients with chronic kidney disease (CKD) defined by an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m², and * one arm of patients with preserved eGFR (≥ 60 mL/min/1.73 m²) but with documented structural or functional kidney damage. All participants will undergo a single application of the wearable device, which non-invasively collects sweat to quantify kidney biomarkers.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evangelia Ntounousi, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047664
- Sponsor's protocol ID
- KERMIT-UOI-01
- Other IDs
- Horizon Europe EIC programme
- Acronym
- KERMIT
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring
- ClinicalTrials.gov ID
- NCT07047664
- Acronym / sponsor ID
- KERMIT / KERMIT-UOI-01
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
Chronic kidney disease (CKD) affects over 10% of the global population, leading to significant morbidity, mortality, and economic burden. Early detection is crucial for preventing disease progression and complications; however, awareness and diagnosis of CKD remain alarmingly low. Current methods rely on blood or urine analysis, which are invasive and require specialized facilities. The KERMIT patch aims to address this gap by providing a wearable lab-on-a-chip device capable of measuring key biomarkers from sweat non-invasively. This innovation has the potential to revolutionize CKD diagnosis, particularly in remote or underserved areas.
The KERMIT patch integrates functional printed biosensors, a high-frequency electrochemical microchip, and a sustainable microfluidic system. Sensors are fabricated using carbon inks and 2D materials, enabling immunodetection and non-enzymatic sensing of creatinine, urea, and cystatin C. Preliminary tests evaluated detection limits, skin compatibility, and carbon footprint.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized, parallel assignment interventional study designed to evaluate the diagnostic performance and safety of an experimental wearable sweat-sensing device. The study includes two parallel arms based on kidney function: * one arm of patients with chronic kidney disease (CKD) defined by an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², and * one arm of patients with preserved eGFR (≥ 60 mL/min/1.73 m²) but with documented structural or functional kidney damage. All participants will undergo a single application of the wearable device, which non-invasively collects sweat to quantify kidney biomarkers.
| Arm | Type | Receives |
|---|---|---|
| CKD with eGFR < 60 mL/min/1.73 m² | Other | Device: KERMIT dermal patchCKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²), and |
| CKD with eGFR ≥ 60 mL/min/1.73 m²) | Other | Device: KERMIT dermal patchCKD patients with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m²) but with documented evidence of kidney damage (e.g., albuminuria, structural or genetic abnormalities). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- eGFR < 60 mL/min/1.73 m², or
- eGFR ≥ 60 mL/min/1.73 m² with documented evidence of kidney damage (persistent albuminuria, structural abnormalities on imaging or histology, or genetic kidney disease).
Key exclusion criteria (13 listed)
- Any signs of dermal infections, open wounds, or skin irritation.
- Significant variations in eGFR in the last two months, defined as any absolute change (either increase or decline) in eGFR of >10 mL/min/1.73m2 ;
- Patients with a functioning kidney graft;
- Patients receiving immunosuppression treatment;
- Patients with kidney stones;
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 |
|---|---|---|
| KERMIT dermal patchThe KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function. | Device | CKD with eGFR < 60 mL/min/1.73 m² |
| KERMIT dermal patchThe KERMIT patch is a non-invasive, wearable device designed to collect sweat and measure concentrations of kidney function biomarkers, including creatinine, urea, and cystatin C. The patch integrates printed biosensors and a microfluidic system for electrochemical detection. It is applied to the skin for a short duration (typically <1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function. | Device | CKD with eGFR ≥ 60 mL/min/1.73 m²) |
Primary outcome
Creatinine concentration in sweat
Time frame: Day 1 (includes screening, device application, and sample analysis)
Estimate the concentration of creatinine in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage). Unit of Measure: µmol/L
Urea concentration in sweat
Time frame: Day 1 (includes screening, device application, and sample analysis)
Estimate the concentration of urea in sweat and assess its diagnostic accuracy in differentiating CKD patients with reduced kidney function (eGFR < 60 mL/min/1.73 m²) from those with preserved kidney function (eGFR ≥ 60 mL/min/1.73 m² but with documented kidney damage). Unit of Measure: mmol/L
Incidence of adverse events related to the wearable device
Time frame: Day 1 (up to 1 hour post-device removal)
Assess the number and severity of adverse events related to the use of the wearable sweat-sensing device, including skin irritation, discomfort, or allergic reactions. Unit of Measure: Number of events, graded by severity (mild, moderate, severe)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing KERMIT dermal patch in people with Chronic Kidney Disease (CKD), run by University of Ioannina.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Creatinine concentration in sweat (time frame: Day 1 (includes screening, device application, and sample analysis)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2025.