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
Are between 18 and 80 years of age and Care Partner is at least 18 years of age at the time of signing consent.
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.
Hgb level of < 9 g/dL at Screening
Persistent pre-dialysis sitting SBP < 100 mmHg despite medical therapy,
Nadir intradialytic Systolic Blood Pressure (SBP) < 90 mmHg, if Subject's pre-HD SBP < 160 mmHg
Nadir intradialytic SBP < 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
Single group
Moda-flx Hemodialysis System™
DeviceThe Moda-flx Hemodialysis System™ is a portable hemodialysis system
Weekly Standardized Dialysis Adequacy
Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Adverse Event (AE) Rate
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.
Goal Ultrafiltration Volume
Compliance with fluid removal goals that are defined as: Ultrafiltration (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.
Study Emergent Pre-Specified Adverse Events
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: 1\. A composite of: * Serious Adverse Event * Allergic Reaction * Blood Loss * Hemolytic Reaction * Infection * Intradialytic Event * Vascular Access Complication * Pyrogenic Reaction
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