Health TrialsbyHealthPanel

KERMIT: Sweat Patch for Early Kidney Disease Detection

ConditionChronic Kidney Disease (CKD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ioannina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • KERMIT dermal patch

    Device

    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 patch

    Device

    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.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: CKD with eGFR < 60 mL/min/1.73 m²Other 1 intervention
Group B: CKD with eGFR ≥ 60 mL/min/1.73 m²)Other 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1 (includes screening, device application, and sample analysis)
2

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

Time frame
Day 1 (includes screening, device application, and sample analysis)
3

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)

Time frame
Day 1 (up to 1 hour post-device removal)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ioannina

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: