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Not yet recruiting NCT07047664

KERMIT: Sweat Patch for Early Kidney Disease Detection

No phase Interventional Chronic Kidney Disease (CKD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KERMIT dermal patch, KERMIT dermal patch.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease (CKD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring

Overview

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

  • 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 fun
  • 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 fun

Primary outcome measures

  • Creatinine concentration in sweat [Time frame: Day 1 (includes screening, device application, and sample analysis)]
  • Urea concentration in sweat [Time frame: Day 1 (includes screening, device application, and sample analysis)]
  • Incidence of adverse events related to the wearable device [Time frame: Day 1 (up to 1 hour post-device removal)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07047664 · KERMIT-UOI-01 · Horizon Europe EIC programme

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗