[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fresenius Medical Care Deutschland GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":242},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,73,98,122,144,170,191,215],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100645232","analysis-of-continuous-kidney-replacement-therapy-ckrt-treatments-with-multiflux-hemofilters-using-regional-citrate-anticoagulation-rca-or-systemic-heparin-anticoagulation-100645232",false,"NCT07679568","Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation","Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation","RCA-Flux","Inclusion Criteria:\n\nGeneral:\n\nPatients ≥ 18 years:\n\n* Informed consent signed and dated by the investigator; and\n\n  1. if patient is able to give consent: by the study patient\n  2. if patients unable to give consent: by the legal representative\u002Fspouse according to § 1358 BGB or\n  3. if an emergency situation is determined: by an independent consultant physician.\n\n     Pediatric Patients \\\u003C 18 years:\n* Informed consent signed and dated by legal representative and investigator\u002F authorized physician.\n* The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.\n* The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator\n\nStudy specific:\n\n* Body weight ≥ 8kg\n* Acute Kidney Injury (AKI) with clinical indication for CKRT\n* Clinically estimated life expectancy greater than 3 days\n\nExclusion Criteria:\n\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations\n* Participation in a different interventional clinical study during the preceding 30 days\n* Previous participation in the same study\n* Uncontrolled bleeding and coagulation disorders","ALL","1 Year",{"count":20,"type":21},62,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to assess the performance of the multiFlux hemofilterwith regional or systemic anticoagulation during CKRT treatments. The multiFlux hemofilter is a single use device within the extracorporeal blood circuit during extracorporeal blood purification treatments for acute renal replacement therapies.",[25,26],"Acute Kidney Injury","Renal Failure",[28,29,30],"Continuous kidney replacement therapy","Regional citrate anticoagulation","Systemic heparin anticoagulation","NOT_YET_RECRUITING","2026-06-25",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":21},"2026-07",{"date":39,"type":21},"2027-12",{"name":41,"class":42},"Fresenius Medical Care Deutschland GmbH","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100545497","clinical-performance-of-the-new-plasma-filter-px2-in-tpe-treatments-100545497","NCT06382675","Clinical Performance of the New Plasma Filter PX2 in TPE Treatments","Clinical Performance of the New Plasma Filter PX2 in Combination With the multiFiltrate and multiFiltratePRO in TPE Treatments","plasmaFlux","Inclusion Criteria:\n\n* Informed consent signed and dated by study patient and investigator\u002Fauthorized physician\n* Minimum age of 18 years\n* Patients with an indication for a therapeutical plasma exchange\n* Patients to be treated with the plasma filter PX2 in combination with the multiFiltrate or multiFiltratePRO\n* No contraindication against systemic anticoagulation\n* Ability to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Patients with known or suspected hypersensitivity to any of the materials of the PX2 plasma filter (Polysulfone, Polyvinylpyrrolidone, Polypropylene, Polyurethane, Silicone) and trial related products\n* Patients suffering from a heparin allergy\n* Patients with a prescription for TPE treatment with the completion of \\\u003C 0.8 PV and \\> 2.0 PV\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Women of childbearing age (\\\u003C 55 years) without effective means of contraception, pregnancy (pregnancy test will be conducted at start) or lactation period\n* Participation in a different interventional clinical study during the preceding 30 days\n* Previous participation in this investigation","18 Years",{"count":54,"type":21},46,"INTERVENTIONAL",[57],"NA","The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.\n\nThe investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment.",[60],"Autoimmune Diseases",[62],"Therapeutical Plasma Exchange","RECRUITING","2026-06-22",{"date":66,"type":35},"2026-06-24",{"date":68,"type":35},"2024-07-18",{"date":70,"type":21},"2027-03",{"name":41,"class":42},7,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":43},"100604946","pd-catheter-data-collection-100604946","NCT07156123","PD Catheter Data Collection","Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters","Catheter","Inclusion Criteria:\n\n* Signed and dated informed consent for study participation and data submission (by the patient or legal representative for patients under 18) along with investigator\u002Fauthorized physician signature.\n* Patients under 18 who have received age- and maturity-appropriate information per Article 63(2) MDR from trained investigators or team members; minors capable of understanding must also sign the informed consent.\n* The investigator must respect the decision of any minor, capable of understanding the information as per Article 63(2) MDR, to decline participation or withdraw from the clinical investigation at any time.\n* Ability to understand the nature and requirements of the study.\n* Patients with indication for renal replacement therapy, specifically PD (CAPD or APD)\n* Patients who began PD using FME catheters within the last 18 months and are either prevalent in PD at study initiation or have switched to HD or undergone transplantation and can consent to data use.\n* Incident patients who will begin PD using FME catheters.\n\nExclusion Criteria:\n\n* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations,\n* Previous participation in the same study.\n* Life expectancy \\\u003C 3 months.",{"count":82,"type":21},300,"Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.",[85],"Renal Insufficiency \u002F Therapy",[87,88,89,79],"Peritoneal dialysis","Renal replacement therapy","Ultrafiltration","2026-04-08",{"date":92,"type":35},"2026-04-09",{"date":94,"type":21},"2026-04",{"date":96,"type":21},"2029-12",{"name":41,"class":42},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":55,"phases":108,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100546104","clinical-performance-of-the-therapy-option-flexpoint-of-the-pd-cycler-sleepsafe-harmony-100546104","NCT06390592","Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony","Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony","FlexPoint","Inclusion Criteria:\n\n* Informed consent signed and dated by study patient and investigator\u002F authorised physician\n* Minimum age of 18 years\n* CKD patients with indication for renal replacement therapy\n* Patients being treated with APD for at least 3 months\n* Patients using the sleep•safe harmony PD cycler (version 3.1)\n* Fluid status regularly monitored with Body Composition Monitor (BCM)\n* Proper functioning catheter\n* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O\n* Ability to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Any conditions which could interference with the patient's ability to comply with the study\n* Previous participation in the same study\n* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)\n* Patients receiving polyglucose containing PD solution\n* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation\n* Patients who suffer from peritonitis\u002Fexit site infection during the last 4 weeks\n* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period\n* Life expectancy \\\u003C3 months\n* Participation in an interventional clinical study during the preceding 90 days",{"count":107,"type":21},24,[57],"Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony",[26,111],"Chronic Kidney Disease",[88,87,113,114],"Automated peritoneal dialysis","PD cycler",{"date":116,"type":35},"2026-04-13",{"date":118,"type":21},"2026-06",{"date":120,"type":21},"2027-05",{"name":41,"class":42},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":55,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":141,"leadSponsor":143,"locationsCount":43},"100542329","comparison-of-individualized-sodium-management-versus-standard-treatment-in-hemodialysis-100542329","NCT06341452","Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis","SODIAH","Inclusion Criteria:\n\nGeneral:\n\n* Informed consent signed and dated by study patient and authorized physician\n* Minimum age of 18 years\n* The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare her\u002Fhis consent for participation in the clinical trial\n* Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml\u002Fmin or less) on dialysis as extracorporeal renal replacement therapy.\n\nStudy-specific:\n\n* Patients on dialysis (HD\u002FHDF), at least 4h treatment time thrice weekly ≥ 3 months using a standard dialysate with a prescribed sodium concentration of 136 mmol\u002FL\n* Anuric patients (\\\u003C300mL\u002Fd; 1 measurement within last 4 weeks)\n* Patient fulfils one of the four following criteria:\n\ninterdialytic weight gain over 4% of dry weight (mean value during run-in period) OR pre-dialytic systolic blood pressure over 180 mmHg (mean value during run-in period) OR intradialytic morbid events (hypotension, hypertension, cramps, headache) in at least three sessions during run-in period OR volume overload according to BCM (FO ≥2.5 L pre-dialysis or relative FO pre-dialysis ≥15% for men and ≥13% for women; one measurement during run-in period)\n\n\\- Patients with a diffusive Na load of at least 1 mmoL\u002F(L TBW) or 0.06g NaCl\u002F(L TBW) (mean value during the run-in period).\n\nExclusion Criteria:\n\nGeneral:\n\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Patient is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations\n* In case of female patients: pregnancy (pregnancy test will be conducted at start and end of study with female patients aged ≤55 years) or lactation period\n* Participation in an interventional clinical study during the preceding 30 days\n* Previous participation in the same study\n\nStudy-specific:\n\n* Patients treated with individualized sodium management over the last 3 months\n* Severe hypoalbuminemia (≤30 g\u002FL; 1 measurement within last 4 weeks)\n* Hypernatremia (pre-dialytic plasma sodium concentration ≥145mmol\u002FL; 1 measurement within last 4 weeks)\n* Uncontrolled diabetic patients with glycated hemoglobin (HbA1C) \\>8%; 1 measurement within last 4 weeks\n* Impossible reliable measurement of the different compartments by bioimpedance due to lower limb amputation or wearing of a unipolar pacemaker or metallic prostheses\n* Life expectancy less than 6 months\n* ONLINEplus HF treatments\u002Fhemofiltration treatments\n* Single-needle treatments\n* Dry weight \\\u003C 40kg\n* Active or chronic infections (HIV, SARS-CoV-2, HBV, HCV)",{"count":130,"type":21},130,[57],"The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing.",[134],"End Stage Renal Disease",[136],"Hemodialysis","2025-12-16",{"date":139,"type":35},"2025-12-22",{"date":137,"type":35},{"date":142,"type":21},"2026-12",{"name":41,"class":42},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":52,"enrollmentInfo":152,"targetDuration":4,"studyType":55,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":43},"100562450","analysis-of-paediatric-treatments-with-multifiltratepro-100562450","NCT06603324","Analysis of Paediatric Treatments With multiFiltratePRO","Efficacy and Safety of Paediatric CVVHD Treatment With MultiFiltratePRO: A Prospective Multicenter Study","ECHOped","Inclusion criteria:\n\nGeneral:\n\n* Paediatric Patients:\n* Informed consent signed and dated by legal representative and investigator\u002F authorized physician.\n* The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children.\n* The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator.\n\nStudy-specific:\n\n* Estimated life expectancy greater than 3 days\n* Children under 18 years\n* Body weight ≥8kg and \\\u003C40kg\n* Patients with clinical indication for CVVHD\n\nExclusion criteria:\n\nGeneral:\n\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations\n* In case of female patients: pregnancy or lactation period\n* Participation in an interventional clinical study during the preceding 30 days\n* Previous participation in the same study\n\nStudy-specific:\n\n* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II)\n* Uncontrolled bleeding and coagulation disorders\n* Decision to limit therapeutic interventions\n* Inability to establish the required vascular access",{"count":153,"type":21},43,[57],"This clinical study evaluates the performance of the MultifiltratePro in pediatric mode for Continuous Venovenous Hemodiafiltration (CVVHD) in children. Its primary aim is to assess the efficacy of the MultifiltratePro in paediatric mode, specifically in achieving at least 80% of the prescribed effluent dose within 72 hours. Additionally, the study focuses on the safety of this mode in a paediatric setting, closely monitoring for clinical adverse events, hemodynamic instability, and electrolyte imbalances. Paediatric patients with body weights between 8kg and 40kg will be treated with the MultifiltratePro for a period of up to 10 days, with the treatment duration and approach being tailored to the severity of each patient's condition.",[26,157],"CVVHD",[25,159,160,161,162],"Renal Replacement Therapy","Haemodiafiltration","Contintious kidney replacement therapy","Paediatric","2025-08-27",{"date":165,"type":35},"2025-09-04",{"date":167,"type":21},"2025-10",{"date":142,"type":21},{"name":41,"class":42},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"100536996","analysis-of-tpe-treatments-with-multifiltratepro-100536996","NCT06272084","Analysis of TPE Treatments With multiFiltratePRO","TPEopt","Inclusion Criteria:\n\n* Body weight ≥40kg irrespective of the age\n* Patients with indication for TPE treatment according to ASFA guideline\n* Patients have been treated with TPE between January 2019 and October 2023\n* Availability of at least 50% of the parameters to be documented for the patient\n\nExclusion Criteria:\n\n* Participation in an interventional clinical study during the retrospectively collected TPE treatment data\n* Previous documentation within this study\n* Simultaneous use of another filter for additional therapy form",{"count":178,"type":21},60,"Analysis of therapeutic plasma exchange (TPE) treatments to assess the performance of the TPE mode of multiFiltratePRO based on the successful exchange of plasma from whole blood. The multiFiltratePRO is a device for extracorporeal blood purification treatments.",[60],[62,182],"ASFA Guideline",{"date":184,"type":35},"2025-08-28",{"date":186,"type":35},"2024-05-22",{"date":188,"type":21},"2025-12",{"name":41,"class":42},3,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":213,"locationsCount":214},"100460984","retrospective-analysis-of-performance-and-treatment-data-collected-for-genius-sleddflux-filter-ultraflux-av-600-s-filter--genius-90-concentrates-in-haemodialysis-patients-100460984","NCT05282732","Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients","Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Acute Haemodialysis, Haemodynamically Instable Patients and Chronic Haemodialysis Patients","Genius","Inclusion Criteria:\n\n* All patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between January 2019 and December 2019, with the investigational devices have to be included in the study in chronological order.\n* For aHD patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments.\n* For cHD patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week\n\nExclusion Criteria:\n\n* Simultaneous use of another filter\u002Fadsorber for another form of therapy",{"count":200,"type":21},100,"Retrospective analysis of performance and treatment data collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter \\& Genius 90 Concentrates in acute haemodialysis, haemodynamically instable patients and chronic haemodialysis patients\n\n* to analyse performance and treatment data from patients treated with the investigational device\n* to evaluate the filter characteristics for aHD (Acute haemodialysis) patients\n* to evaluate the improvement of kidney function for aHD patients",[26,134,203],"Acute Renal Failure",[136,205,206],"Genius system","Slow extended daily dialysis","2025-06-17",{"date":209,"type":35},"2025-06-22",{"date":211,"type":35},"2022-10-07",{"date":188,"type":21},{"name":41,"class":42},2,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":223,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":55,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100593320","efficacy-and-tolerability-of-the-apd-treatment-in-paed-patients-100593320","NCT07004907","Efficacy and Tolerability of the APD Treatment in PAED Patients","Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler","SilenciaPAED","Inclusion Criteria:\n\n* Informed consent signed and dated by legal representative and investigator\u002Fauthorized physician\n* The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children\n* The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator\n* patients with renal failure treated or planned to be treated with APD\n* Body weight ≤ 20 kg\n* Ability to understand the nature and requirements of the study\n\nExclusion Criteria:\n\n* Any conditions which could interfere with the patient's ability to comply with the study\n* Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations\n* Participation in an interventional clinical study during the preceding 30 days\n* Previous participation in the same study\n* Life expectancy \\\u003C 3 months\n* Patients who suffer from peritonitis\u002Fexit site infection during the last 4 weeks","0 Months",{"count":225,"type":21},13,[57],"The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt\u002FVurea ≥ 1.8.",[229],"Renal Failure Acute Chronic",[113,231,232,233,111],"paedriatic patients","Kt\u002FV","ultrafiltration","2025-06-02",{"date":236,"type":35},"2025-06-04",{"date":238,"type":21},"2026-01",{"date":240,"type":21},"2026-11",{"name":41,"class":42},""]