Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis

Troy J. Plumb, Luis Alvarez, Dennis L. Ross, Joseph J. Lee, Jeffrey G. Mulhern, Jeffrey L. Bell, Graham Abra, Sarah S. Prichard, Glenn M. Chertow, Michael A. Aragon

Research output: Contribution to journalArticle

Abstract

Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. Conclusion: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

Original languageEnglish (US)
JournalHemodialysis International
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Home Hemodialysis
Renal Dialysis
Ultrafiltration
Safety
Cross-Over Studies
Caregivers
Research Personnel
Delivery of Health Care
Equipment and Supplies
Therapeutics

Keywords

  • Adequacy of dialysis
  • hemodialysis
  • hemodialysis delivery systems
  • home
  • kinetics
  • volume control

ASJC Scopus subject areas

  • Hematology
  • Nephrology

Cite this

Plumb, T. J., Alvarez, L., Ross, D. L., Lee, J. J., Mulhern, J. G., Bell, J. L., ... Aragon, M. A. (Accepted/In press). Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis. Hemodialysis International. https://doi.org/10.1111/hdi.12795

Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis. / Plumb, Troy J.; Alvarez, Luis; Ross, Dennis L.; Lee, Joseph J.; Mulhern, Jeffrey G.; Bell, Jeffrey L.; Abra, Graham; Prichard, Sarah S.; Chertow, Glenn M.; Aragon, Michael A.

In: Hemodialysis International, 01.01.2019.

Research output: Contribution to journalArticle

Plumb, TJ, Alvarez, L, Ross, DL, Lee, JJ, Mulhern, JG, Bell, JL, Abra, G, Prichard, SS, Chertow, GM & Aragon, MA 2019, 'Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis', Hemodialysis International. https://doi.org/10.1111/hdi.12795
Plumb, Troy J. ; Alvarez, Luis ; Ross, Dennis L. ; Lee, Joseph J. ; Mulhern, Jeffrey G. ; Bell, Jeffrey L. ; Abra, Graham ; Prichard, Sarah S. ; Chertow, Glenn M. ; Aragon, Michael A. / Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis. In: Hemodialysis International. 2019.
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abstract = "Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10{\%} of prescribed UF. We collected safety and usability data. Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96{\%} in-center and 99{\%} in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5{\%}) of measurements during the In-Center period and 168/171 (98.3{\%}) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94{\%} in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. Conclusion: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.",
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AU - Alvarez, Luis

AU - Ross, Dennis L.

AU - Lee, Joseph J.

AU - Mulhern, Jeffrey G.

AU - Bell, Jeffrey L.

AU - Abra, Graham

AU - Prichard, Sarah S.

AU - Chertow, Glenn M.

AU - Aragon, Michael A.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. Conclusion: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

AB - Introduction: Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers. Methods: A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/Vurea ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data. Findings: Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/Vurea was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. Conclusion: Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.

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KW - kinetics

KW - volume control

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