[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596607":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":23,"locations":23,"responsibleParty":26,"collaborators":23,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":23,"enrollmentInfo":40,"targetDuration":23,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":49,"overallStatus":51,"whyStopped":23,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":23},{"fullName":5,"class":6},"University of Ioannina","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"CKD with eGFR \u003C 60 mL\u002Fmin\u002F1.73 m²","CKD patients with reduced kidney function (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²), and",[12],"Device: KERMIT dermal patch",{"label":14,"type":6,"description":15,"interventionNames":16},"CKD with eGFR ≥ 60 mL\u002Fmin\u002F1.73 m²)","CKD patients with preserved kidney function (eGFR ≥ 60 mL\u002Fmin\u002F1.73 m²) but with documented evidence of kidney damage (e.g., albuminuria, structural or genetic abnormalities).",[12],[18,24],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"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 \\\u003C1 hour), with pilocarpine stimulation. This study evaluates the patch's performance in differentiating between CKD patients with reduced versus preserved renal function.",[9],null,{"type":19,"name":20,"description":21,"armGroupLabels":25,"otherNames":23},[14],{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Evangelia Ntounousi","Ass. Prof. of Nephrology, Head of Nephrology Department","100596607","kermit-sweat-patch-for-early-kidney-disease-detection-100596607",false,"NCT07047664","KERMIT: Sweat Patch for Early Kidney Disease Detection","Kidney Disease Sweat Sensor Patch for Early Diagnosis and Remote MonIToring","KERMIT","Inclusion Criteria:\n\nAdults aged ≥18 years with stable CKD, defined as:\n\n* eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m², or\n* eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² with documented evidence of kidney damage (persistent albuminuria, structural abnormalities on imaging or histology, or genetic kidney disease).\n\nExclusion Criteria:\n\n* Any signs of dermal infections, open wounds, or skin irritation.\n* Significant variations in eGFR in the last two months, defined as any absolute change (either increase or decline) in eGFR of \\>10 mL\u002Fmin\u002F1.73m2 ;\n* Patients with a functioning kidney graft;\n* Patients receiving immunosuppression treatment;\n* Patients with kidney stones;\n* Patients with uncontrolled hypertension (a systolic blood pressure (SBP) \\>150 mmHg and\u002For diastolic blood pressure (DBP) \\>90 mmHg with measurements taken under standardized conditions (e.g after a 5-minute seated rest, using validated equipment);\n* Patients receiving drugs reported to affect serum levels of creatinine and cystatin-c without affecting kidney function (i.e. cimetidine, trimethoprim, and fibrates);\n* Known allergy to pilocarpine,\n* Glaucoma;\n* Patients with metal implants;\n* Pregnancy;\n* Active malignancy;\n* Low life expectancy (\\\u003C6 months) according to investigators judgement","ALL","18 Years",{"count":41,"type":42},52,"ESTIMATED","INTERVENTIONAL",[45],"NA","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.\n\nThe 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.",[48],"Chronic Kidney Disease (CKD)",[50],"CKD","NOT_YET_RECRUITING","2025-06-23",{"date":54,"type":55},"2025-07-02","ACTUAL",{"date":57,"type":42},"2025-07-01",{"date":59,"type":42},"2026-07",{"name":5,"class":6}]