Chronic Kidney Disease (CKD)
Conditions
Keywords
CKD
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.
Interventions
DEVICEKERMIT 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.
Sponsors
University of Ioannina
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a non-randomized, parallel assignment interventional study designed to evaluate the diagnostic performance and safety of an experimental wearable sweat-sensing device. The study includes two parallel arms based on kidney function: * one arm of patients with chronic kidney disease (CKD) defined by an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m², and * one arm of patients with preserved eGFR (≥ 60 mL/min/1.73 m²) but with documented structural or functional kidney damage. All participants will undergo a single application of the wearable device, which non-invasively collects sweat to quantify kidney biomarkers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Outcome results
None listed