KERMIT: Sweat Patch for Early Kidney Disease Detection

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.

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Key information

Conditions

Chronic Kidney Disease (CKD) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

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);
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

Treatment and study plan

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.

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring

Acronym: KERMIT

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Jul 2, 2025
Registry last updated: Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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