Sistema de Hemodiálisis Moda-flx para Enfermedad Renal en Etapa Terminal

Fecha de inicio: 6 de octubre de 2025

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.