protocolSection identificationModule nctId: NCT06314503, orgStudyIdInfo id: 23-075_CORDIAL_FIH, secondaryIdInfos id: NL83843.000.23, type: OTHER, domain: CCMO (Centrale Commissie Mensgebonden Onderzoek), briefTitle: First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients, acronym: CORDIAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: European Commission, Horizon 2020, collaborators name: Dutch Kidney Foundation, collaborators name: Health Holland, collaborators name: Nanodialysis Ltd, collaborators name: Università degli studi di Modena e Reggio Emilia (UNIMORE), collaborators name: Servicio Madrileno De Salud (SERMAS), collaborators name: PPI Healthcare Consulting Ltd, descriptionModule briefSummary: The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane)., conditionsModule conditions: Renal Insufficiency, Chronic, conditions: Kidney Failure, Chronic, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study has a first-in-human, prospective, open-label, non-randomized, three-center, single-arm design., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: WEAKID, outcomesModule primaryOutcomes measure: Serious adverse device effects (SADEs) and device deficiencies (DDs), primaryOutcomes measure: Critical changes in blood pressure, primaryOutcomes measure: Critical changes in heart rate, primaryOutcomes measure: Critical changes in body temperature, primaryOutcomes measure: Critical changes in oxygen saturation, primaryOutcomes measure: Critical changes in plasma potassium, primaryOutcomes measure: Critical changes in plasma calcium, primaryOutcomes measure: Critical changes in plasma bicarbonate, primaryOutcomes measure: Critical changes in intra-abdominal dialysate volume, primaryOutcomes measure: Critical changes in intra-abdominal pressure, secondaryOutcomes measure: Adverse events (AEs) and device deficiencies (DDs), secondaryOutcomes measure: Number of WEAKID treatments, secondaryOutcomes measure: Duration of WEAKID treatments, secondaryOutcomes measure: Dialysate flow rates during WEAKID treatment, secondaryOutcomes measure: Evolution of blood pressure, secondaryOutcomes measure: Evolution of heart rate, secondaryOutcomes measure: Evolution of body temperature, secondaryOutcomes measure: Evolution of oxygen saturation, secondaryOutcomes measure: Ultrafiltration volume, secondaryOutcomes measure: Peak glucose concentration in the device effluent, secondaryOutcomes measure: Ultrafiltration efficiency, secondaryOutcomes measure: Removal of urea by the WEAKID system, secondaryOutcomes measure: Removal of creatinine by the WEAKID system, secondaryOutcomes measure: Removal of phosphate by the WEAKID system, secondaryOutcomes measure: Removal of potassium by the WEAKID system, secondaryOutcomes measure: Removal of uric acid by the WEAKID system, secondaryOutcomes measure: Removal of beta-2 microglobulin by the WEAKID system, secondaryOutcomes measure: Removal of vitamin B12 by the WEAKID system, secondaryOutcomes measure: Mass transfer area coefficient of urea, secondaryOutcomes measure: Mass transfer area coefficient of creatinine, secondaryOutcomes measure: Mass transfer area coefficient of phosphate, secondaryOutcomes measure: Mass transfer area coefficient of potassium, secondaryOutcomes measure: Mass transfer area coefficient of uric acid, secondaryOutcomes measure: Mass transfer area coefficient of beta-2 microglobulin, secondaryOutcomes measure: Mass transfer area coefficient of vitamin B12, secondaryOutcomes measure: Plasma clearance of urea, secondaryOutcomes measure: Plasma clearance of creatinine, secondaryOutcomes measure: Plasma clearance of phosphate, secondaryOutcomes measure: Plasma clearance of potassium, secondaryOutcomes measure: Plasma clearance of uric acid, secondaryOutcomes measure: Plasma clearance of beta-2 microglobulin, secondaryOutcomes measure: Plasma clearance of vitamin B12, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenine, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid, secondaryOutcomes measure: The plasma reduction ratio of the protein-bound uremic toxin hippuric acid, secondaryOutcomes measure: The release of base, secondaryOutcomes measure: Evolution of plasma levels of urea, secondaryOutcomes measure: Evolution of plasma levels of creatinine, secondaryOutcomes measure: Evolution of plasma levels of uric acid, secondaryOutcomes measure: Evolution of plasma levels of beta-2 microglobulin, secondaryOutcomes measure: Evolution of plasma levels of phosphate, secondaryOutcomes measure: Evolution of plasma levels of potassium, secondaryOutcomes measure: Evolution of plasma levels of bicarbonate, secondaryOutcomes measure: Evolution of plasma levels of lactate, secondaryOutcomes measure: Evolution of plasma levels of sodium, secondaryOutcomes measure: Evolution of plasma levels of chloride, secondaryOutcomes measure: Evolution of plasma levels of calcium, secondaryOutcomes measure: Evolution of plasma levels of magnesium, secondaryOutcomes measure: Evolution of plasma levels of glucose, secondaryOutcomes measure: Evolution of plasma levels of lactate dehydrogenase, secondaryOutcomes measure: Evolution of plasma levels of vitamin B12, secondaryOutcomes measure: Evolution of plasma levels of albumin, secondaryOutcomes measure: Evolution of plasma leucocyte count, secondaryOutcomes measure: Evolution of plasma thrombocyte count, secondaryOutcomes measure: Evolution of plasma levels of C-reactive protein (CRP), secondaryOutcomes measure: Evolution of plasma levels of bilirubin, secondaryOutcomes measure: Evolution of plasma levels of aspartate transaminase (ASAT), secondaryOutcomes measure: Evolution of plasma levels of alanine aminotransferase (ALAT), secondaryOutcomes measure: Evolution of sodium levels in dialysate effluent, secondaryOutcomes measure: Evolution of chloride levels in dialysate effluent, secondaryOutcomes measure: Evolution of calcium levels in dialysate effluent, secondaryOutcomes measure: Evolution of magnesium levels in dialysate effluent, secondaryOutcomes measure: Evolution of bicarbonate levels in dialysate effluent, secondaryOutcomes measure: Evolution of lactate levels in dialysate effluent, secondaryOutcomes measure: Evolution of pH of dialysate effluent, secondaryOutcomes measure: Total number of device deficiencies and adverse device effects, secondaryOutcomes measure: Evolution of delta intraperitoneal pressure during WEAKID treatment, secondaryOutcomes measure: Patient tolerance (abdominal discomfort), secondaryOutcomes measure: Evolution of uremic symptoms, secondaryOutcomes measure: Usability, otherOutcomes measure: Baseline characteristics, otherOutcomes measure: Peritoneal equilibrium tests, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università degli studi di Modena e Reggio Emilia (UNIMORE), status: NOT_YET_RECRUITING, city: Modena, zip: 41121, country: Italy, contacts name: Gabriele Donati, Prof., MD, PhD, role: CONTACT, phone: +39-0594225331, email: gabriele.donati@unimore.it, contacts name: Giulia Ligabue, MSc, PhD, role: CONTACT, phone: +39-0594224175, email: giulia.ligabue@unimore.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: University Medical Center Utrecht (UMCU), status: RECRUITING, city: Utrecht, zip: 3584 CX, country: Netherlands, contacts name: Karin GF Gerritsen, MD, PhD, role: CONTACT, phone: +31-887557375, email: k.g.f.gerritsen@umcutrecht.nl, contacts name: Dian P Bolhuis, MSc, role: CONTACT, phone: +31-887557375, email: d.p.bolhuis-3@umcutrecht.nl, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Hospital Universario La Paz (SERMAS), status: NOT_YET_RECRUITING, city: Madrid, zip: 28029, country: Spain, contacts name: Gloria del Peso Gilsanz, MD, PhD, role: CONTACT, phone: +34-913585339, email: gloria.delpeso@salud.madrid.org, contacts name: Maria A Bajo Rubio, MD, PhD, role: CONTACT, phone: +34-913585339, email: mauxiliadora.bajo@salud.madrid.org, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False