Overview

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

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Hgb level of < 9 g/dL at Screening
• 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.