Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-28 @ 5:33 AM
Study NCT ID:
NCT06613568
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly Standardized Dialysis Adequacy', 'timeFrame': 'Up to 10 weeks per period', 'description': 'Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings'}, {'measure': 'Adverse Event (AE) Rate', 'timeFrame': 'Up to 10 weeks per period', 'description': 'The adverse event (AE) rate: defined as the number of Study Emergent AEs per 100 dialysis treatments 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 10 weeks per period', 'description': 'Compliance with fluid removal goals that are defined as:\n\nUltrafiltration (net fluid removal), such that the recorded value from the Moda-flx Hemodialysis System™ is within ± 100 mL/h or ± 250 mL (whichever is less) of set point during the treatment, based on the UF prescription.'}, {'measure': 'Study Emergent Pre-Specified Adverse Events', 'timeFrame': 'Up to 10 weeks per period', 'description': 'Study Emergent Pre-Specified Adverse Eventss, categorized by study period (Professional Care and At Home) severity, device relationship and procedure relationship. Study-emergent Pre-Specified AEs are those AEs with an onset on or after the date of first treatment during the Run-In Period, which 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'}]}, 'oversightModule': {'oversightHasDmc': False, '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': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/V ≥ 1.2 OR stdKt/V ≥ 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/min 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 \\< 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\n* Participant had an average ultrafiltration rate \\> 13 mL/kg/hour 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."}, '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 Participants 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': {'locations': [{'zip': '91773', 'city': 'San Dimas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Way', 'role': 'CONTACT', 'email': 'mpruitt@nariresearch.com', 'phone': '(800) 797-1695'}], 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.10668, 'lon': -117.80673}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Brooks', 'role': 'CONTACT', 'email': 'benjamin.brooks@dciinc.org', 'phone': '865-323-3382'}], 'facility': 'Nephrology Associates of Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rhea Sharma', 'role': 'CONTACT', 'email': 'rheas@aqua-ri.com', 'phone': '281-939-6516'}], 'facility': 'aQua Research Institute, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lori Linke', 'role': 'CONTACT', 'email': 'linkel@uw.edu'}], 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Michael Gastauer', 'role': 'CONTACT', 'email': 'HomeTrial@Diality.com', 'phone': '949-916-5851'}], 'overallOfficials': [{'name': 'Cynthia Silva, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diality Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diality Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}