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Kidney Week

Abstract: TH-PO1195

Safety and Efficacy of the Tablo System: Results from a Prospective, Multi-Center, Cross-Over Study of a First-in-Class Hemodialysis Device in the Home

Session Information

Category: Dialysis

Authors

  • Plumb, Troy J., University of Nebraska Medical Center, Omaha, Nebraska, United States
  • Alvarez, Luis, Palo Alto Medical Foundation, Menlo Park, California, United States
  • Ross, Dennis L., Kansas Nephrology Physicians, P.A., Wichita, Kansas, United States
  • Lee, Joseph J., Nephrology Associates Medical Group, Riverside, California, United States
  • Mulhern, Jeffrey, Tufts University School of Medicine, Boston, Massachusetts, United States
  • Abra, Graham E., Satellite Healthcare, San Jose, California, United States
  • Prichard, Sarah S., Independent Consultant, Montreal, Quebec, Canada
  • Chertow, Glenn Matthew, Stanford University School of Medicine, Palo Alto, California, United States
  • Aragon, Michael A., Outset Medical, San Jose, California, United States
Background

Home dialysis is in critical need of new technology to facilitate its delivery, as evidenced by the recent Advancing American Kidney Health initiative. The Tablo™ Hemodialysis System (Tablo) is the first new technology expanding to home use in nearly 15 years, designed to simplify patient self-care through automation, integrating on-demand water purification and dialysate production. This investigational device exemption (IDE) study assessed the safety and efficacy of Tablo managed in-center by healthcare professionals and in-home by patients or caregivers.

Methods

We conducted a prospective, multicenter, open label, cross-over trial comparing in-center and in-home hemodialysis using Tablo. Dialysis was prescribed four times per week during four treatment periods: 1-week Run-In, 8-week In-Center, approximately 4-week Transition and 8-week In-Home. The primary efficacy endpoint was achieving weekly standardized Kt/Vurea > 2.1. The secondary efficacy endpoint was delivered ultrafiltration within 10% of prescribed. We also collected safety and usability data.

Results

Thirty participants enrolled, and 28 completed all trial periods. Adherence to the four treatment per week prescription was 96% in-center and 99% in-home. The average prescribed and delivered treatment session lengths were 3.4 hours for the In-Center and In-Home periods.The primary efficacy endpoint was achieved in 199/200 (99.5%) measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standardized Kt/Vureawas 2.8 in both periods. The ultrafiltration endpoint was achieved in 94% of patients during both the in-center and in-home periods. No pre-specified adverse events related to Tablo occurred during any trial period. The resolution time of alarms was 14 seconds in-center and 12 seconds in-home.

Conclusion

Tablo exceeds the target stdKt/Vurea > 2.1 for in-center and home care settings with highly accurate ultrafiltration. With patient-centric design, infrequent and easy to resolve alarms, and a demonstrated safety profile, Tablo provides a new option for expanding home dialysis in the United States, aligning with ambitious targets recently set by policymakers.

Funding

  • Commercial Support