Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
NCT ID: NCT06613568
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-10-06
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Professional Care and At Home
Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting
Moda-flx Hemodialysis System™
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
Interventions
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Moda-flx Hemodialysis System™
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.
Exclusion Criteria
* Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:
1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
* Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study
* Participant had an average ultrafiltration rate \> 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records.
* Had a significant cardiovascular adverse event within the last 90 days prior to Screening.
18 Years
80 Years
ALL
No
Sponsors
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Diality Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Silva, MD
Role: STUDY_DIRECTOR
Diality Inc.
Locations
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North America Research Institute
San Dimas, California, United States
Nephrology Associates of Knoxville
Knoxville, Tennessee, United States
aQua Research Institute, LLC
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Molly Way
Role: primary
Benjamin Brooks
Role: primary
Rhea Sharma
Role: primary
Lori Linke
Role: primary
Other Identifiers
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DIA-HHD-001
Identifier Type: -
Identifier Source: org_study_id