Study Evaluating the Moda-flx Hemodialysis System12 Use in Professional Care and At Home by Adults With End Stage Kidney Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Moda-flx Hemodialysis System12, a portable hemodialysis device, for people with End Stage Kidney Disease (ESKD) who are on stable dialysis treatments. This study includes use of the system both in professional care settings by trained individuals and at home by trained participants and their care partners. The goal is to understand how this system performs when used under different care conditions. Participants will receive dialysis therapy with the Moda-flx Hemodialysis System12 in two settings: a professional care environment and at home. The study is prospective, non-randomized, and open-label, meaning all participants receive the device and both the participants and researchers know the treatment being given. Training and assessment with a care partner are part of the preparation before home use. During the study, participants will be monitored for dialysis adequacy and adverse events over periods of up to 10 weeks in each setting. Researchers will also track ultrafiltration goals and any emergent adverse events. Participants will have vascular access monitored and complete skills assessments with their care partners. The study runs until September 2027, with assessments of safety and treatment performance throughout.

Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants