[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Diality Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100563238","moda-flx-hemodialysis-system-under-professional-care-settings-by-trained-individuals-and-at-home-by-participants-100563238",false,"NCT06613568","Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants","Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Participants With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens","Inclusion Criteria:\n\n* Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent.\n* Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt\u002FV ≥ 1.2 OR stdKt\u002FV ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Screening Period\n* Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml\u002Fmin prior to the end of Screening\n* Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.\n\nExclusion Criteria:\n\n* Hgb level of \\\u003C 9 g\u002FdL at Screening\n* Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:\n\n  1. Persistent pre-dialysis sitting SBP \\\u003C 100 mmHg despite medical therapy,\n  2. Nadir intradialytic Systolic Blood Pressure (SBP) \\\u003C 90 mmHg, if Subject's pre-HD SBP \\\u003C 160 mmHg\n  3. Nadir intradialytic SBP \\\u003C 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg\n* Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study\n* Participant had an average ultrafiltration rate \\> 13 mL\u002Fkg\u002Fhour during the last 2 weeks prior to Screening, per medical records.\n* Had a significant cardiovascular adverse event within the last 90 days prior to Screening.","ALL","18 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners",[27],"End Stage Kidney Disease",[29,30,31,32,33,34,35,36],"Renal Disease","Hemodialysis Complication","Kidney Diseases","Dialysis","Renal Dialysis","Hemodialysis, Home","Renal Insufficiency","Kidney Failure, Chronic","RECRUITING","2025-11-05",{"date":40,"type":41},"2025-11-10","ACTUAL",{"date":43,"type":41},"2025-10-06",{"date":45,"type":21},"2027-09",{"name":47,"class":48},"Diality Inc.","INDUSTRY",4,""]