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Kidney Week

Abstract: TH-PO308

A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis

Session Information

  • Home Dialysis - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

  • 802 Dialysis: Home Dialysis and Peritoneal Dialysis

Authors

  • Komenda, Paul, Quanta Dialysis Technologies Ltd, Alcester, Warwickshire, United Kingdom
  • Hussein, Wael F., Satellite Healthcare, San Jose, California, United States
  • Atray, Naveen K., Capital Nephrology Group, Sacramento, California, United States
  • Bett, Doreen W., DaVita Manheim Pike At Home, Lancaster, Pennsylvania, United States
  • Chan, Christopher T., Toronto General Hospital, Toronto, Ontario, Canada
  • Diamond, Matthew J., Southeastern Clinical Research Institute, Chattanooga, Tennessee, United States
  • Green, Gopa B., Satellite Healthcare, San Jose, California, United States
  • Gupta, Nupur, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Karl, Bethany E., University of California San Diego, La Jolla, California, United States
  • Kattah, Andrea G., Mayo Clinic College of Medicine and Science, Rochester, Minnesota, United States
  • Seek, Melvin, DaVita Ocala Rkchd At Home, Ocala, Florida, United States
  • Watnick, Suzanne, Northwest Kidney Centers, Portland, Oregon, United States
  • Weinhandl, Eric D., Satellite Healthcare, San Jose, California, United States
  • Whitlock, Reid, Seven Oaks General Hospital, Winnipeg, Manitoba, Canada
  • Bismarck, Lisa, Quanta Dialysis Technologies Ltd, Alcester, Warwickshire, United Kingdom
  • Gorbe, Kelley Lee, Quanta Dialysis Technologies Ltd, Alcester, Warwickshire, United Kingdom
Background

Hemodialysis (HD) treatments in the United States (US) are typically delivered in a dialysis center. Home hemodialysis (HHD) reduces costs to healthcare payors while providing more flexibility to patients with kidney failure. The QuantaTM Dialysis System (Quanta Dialysis System) is a modern, user-friendly HD device. Whether it is equally safe and effective when operated by patients and caregivers in the US at home vs. healthcare professionals at a center is unknown. The purpose of this study is to determine non-inferiority of efficacy and safety of the Quanta Dialysis System in self-care HHD vs. in-center HD.

Methods

This is a prospective study set in 12 sites in the US. Adult patients with kidney failure currently undergoing dialysis for ≥90 days were eligible. Enrollment began November 2021 and continued during the Omicron wave of the COVID-19 pandemic. Participants received HD at their respective HHD training centers for 4-8-weeks. While dialyzing, participants and caregivers trained to use the device at home. Once deemed competent by a nephrology care team, participants performed supervised HHD during a transition week, then performed HHD with a care partner for 8 weeks. The primary efficacy outcome is dialysis adequacy measured by mean standardized weekly Kt/V. The primary safety outcome is a composite of adverse events.

Results

As of April 2023, 23 patients were enrolled. The mean age was 55.5 ± 13.1 years, mean weight was 95.6 ± 20.4 kg, 10 (43.5%) participants were female, and 17 (73.9%) had a fistula or a graft for dialysis access. Only 4 (17.4%) participants have previously dialyzed with an HHD device. To date, 15 patients have transitioned from in-center HD to HHD, including 11 (73%) who achieved competency by the 5th week of training. Eight patients have completed the study.

Conclusion

Data on successful completion of training suggests the Quanta Dialysis System is easy to use for patients with kidney failure in the US. As the final participants are projected to complete the study by August 2023, complete safety and efficacy comparisons between use of the Quanta Dialysis System in HHD vs. in-center HD will be reported at the time of presentation.

Funding

  • Commercial Support – Quanta Dialysis Technologies