Study Evaluating the Moda-flx Hemodialysis System for Adults with End Stage Kidney Disease Using Treatment in Care Centers and at Home

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Moda-flx Hemodialysis System for adults with end-stage kidney disease ESKD. The study focuses on treatment administered both in professional care settings by trained individuals and at home by trained participants and their care partners. The goal is to assess how well this portable hemodialysis device supports dialysis therapy in these different environments. Participants will use the Moda-flx Hemodialysis System for their dialysis treatments in both professional care centers and home settings. The device is portable and designed to enable dialysis outside traditional clinical environments. The study includes a training period where participants and care partners must successfully complete a skills and comprehension assessment before proceeding with home use. During the study, participants will be monitored for dialysis adequacy weekly for up to 10 weeks per period, and any adverse events will be tracked. Additional measures include goal ultrafiltration volume and pre-specified adverse events emerging during the study. Participants will undergo assessments of vascular access function and stability before enrollment, with ongoing safety monitoring throughout the treatment periods. The study lasts until primary completion in March 2027, with full completion anticipated by September 2027.

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