Nctid:
NCT06613568
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000007676", "term"=>"Kidney Failure, Chronic"}], "ancestors"=>[{"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000051436", "term"=>"Renal Insufficiency, Chronic"}, {"id"=>"D000051437", "term"=>"Renal Insufficiency"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M10699", "name"=>"Kidney Failure, Chronic", "asFound"=>"End Stage Kidney Disease", "relevance"=>"HIGH"}, {"id"=>"M26718", "name"=>"Renal Insufficiency", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M26717", "name"=>"Renal Insufficiency, Chronic", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Weekly Standardized Dialysis Adequacy", "timeFrame"=>"Up to 16 weeks", "description"=>"Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings"}, {"measure"=>"Adverse Event Rate", "timeFrame"=>"Up to 16 weeks", "description"=>"The adverse event (AE) rate: defined as the number of AEs per 100 dialysis intervals occurring in the At Home period of the study, compared with those occurring during the Professional Care period"}], "secondaryOutcomes"=>[{"measure"=>"Goal Ultrafiltration Volume", "timeFrame"=>"Up to 22 weeks", "description"=>"Compliance with fluid removal goals that are defined as:\n\nThe Goal ultrafiltration volume as reported by the device (measured as a total volume over the whole duration of the treatment) will be within ±10 percent of the weighed ultrafiltration volume."}, {"measure"=>"Incidence of Pre-Specified Adverse Events", "timeFrame"=>"Up to 22 weeks", "description"=>"The total number of Study-Emergent AEs and SAEs (Serious Adverse Events) compared across study periods as well as for each of 3 Subgroups of the Study-Emergent AEs, including Pre-Specified (Anticipated) AEs, Unanticipated (not Pre-Specified) AEs, and Device-Related AEs. Under this analysis, Pre-Specified AEs will be comprised of any of the following:\n\n1. A composite of:\n\n * Serious Adverse Event\n * Allergic Reaction\n * Blood Loss\n * Hemolytic Reaction\n * Infection\n * Intradialytic Event\n * Vascular Access Complication\n * Pyrogenic Reaction\n2. Summary statistics to be displayed for the above individual components across both study periods"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isUnapprovedDevice"=>true, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Renal Disease", "Hemodialysis Complication", "Kidney Diseases", "Dialysis", "Renal Dialysis", "Hemodialysis, Home", "Renal Insufficiency", "Kidney Failure, Chronic"], "conditions"=>["End Stage Kidney Disease"]}, "descriptionModule"=>{"briefSummary"=>"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"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Are between 18 and 75 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/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Run-In Period\n* In the opinion of the Investigator, 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/min prior to the end of the Run-In Period\n* In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period\n\nExclusion Criteria:\n\n* Hgb level of \\< 9 g/dL 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 \\< 100 mmHg despite medical therapy,\n 2. Nadir intradialytic Systolic Blood Pressure (SBP) \\< 90 mmHg, if Subject's pre-HD SBP \\< 160 mmHg\n 3. Nadir intradialytic SBP \\< 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"}, "identificationModule"=>{"nctId"=>"NCT06613568", "briefTitle"=>"Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Diality Inc."}, "officialTitle"=>"Prospective, Non-Randomized, Multicenter, Open-Label Study Evaluating the Use of the Moda-flx Hemodialysis System™ Under Professional Care and At Home by Subjects With End Stage Kidney Disease (ESKD) Who Are on Stable Dialysis Regimens", "orgStudyIdInfo"=>{"id"=>"DIA-HHD-001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Professional Care and At Home", "description"=>"Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At-Home setting", "interventionNames"=>["Device: Moda-flx Hemodialysis System™"]}], "interventions"=>[{"name"=>"Moda-flx Hemodialysis System™", "type"=>"DEVICE", "description"=>"The Moda-flx Hemodialysis System™ is a portable hemodialysis system", "armGroupLabels"=>["Professional Care and At Home"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Michael Gastauer", "role"=>"CONTACT", "email"=>"HomeTrial@Daility.com", "phone"=>"949-916-5851"}], "overallOfficials"=>[{"name"=>"Jennifer Joe, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Diality Inc."}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Diality Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
