KERMIT: Sweat Patch for Early Kidney Disease Detection

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Disease (CKD)

• Registration Number: NCT07047664
• Lead Sponsor: University of Ioannina

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study Start: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2025-12
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events related to the wearable device	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)
Creatinine concentration in sweat	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	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