KERMIT: Sweat Patch for Early Kidney Disease Detection

NCT ID: NCT07047664

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-31

Brief 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. 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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CKD with eGFR < 60 mL/min/1.73 m²

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

Group Type: OTHER

KERMIT dermal patch

Intervention Type: 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.

CKD with eGFR ≥ 60 mL/min/1.73 m²)

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).

Group Type: OTHER

KERMIT dermal patch

Intervention Type: 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.

Interventions

KERMIT dermal patch

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.

Intervention Type: DEVICE

KERMIT dermal patch

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Evangelia Ntounousi

Ass. Prof. of Nephrology, Head of Nephrology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Horizon Europe EIC programme

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KERMIT-UOI-01

Identifier Type: -

Identifier Source: org_study_id