KERMIT: Sweat Patch for Early Kidney Disease Detection

University of Ioannina

Status: Not yet enrolling

Conditions: Chronic Kidney Disease (CKD)

Treatments: Device: KERMIT dermal patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07047664

KERMIT-UOI-01

Horizon Europe EIC programme (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

CKD with eGFR < 60 mL/min/1.73 m²

Other group

Description:

CKD patients with reduced kidney function (eGFR \< 60 mL/min/1.73 m²), and

Treatment:

Device: KERMIT dermal patch

Device: KERMIT dermal patch

CKD with eGFR ≥ 60 mL/min/1.73 m²)

Other group

Description:

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).

Treatment:

Device: KERMIT dermal patch

Device: KERMIT dermal patch