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A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies: A Catalyst for Change.

Authors
  • Bonventre, Joseph V1, 2
  • Hurst, Frank P3
  • West, Melissa4
  • Wu, Iwen5
  • Roy-Chaudhury, Prabir6, 7
  • Sheldon, Murray3
  • 1 Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; [email protected]
  • 2 Harvard Stem Cell Institute, Cambridge, Massachusetts.
  • 3 Center for Devices and Radiological Health and.
  • 4 American Society of Nephrology, Washington, DC.
  • 5 Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
  • 6 Division of Nephrology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina; and.
  • 7 Department of Medicine, WG (Bill) Hefner VA Medical Center, Salisbury, North Carolina.
Type
Published Article
Journal
Clinical Journal of the American Society of Nephrology
Publisher
American Society of Nephrology
Publication Date
Oct 07, 2019
Volume
14
Issue
10
Pages
1539–1547
Identifiers
DOI: 10.2215/CJN.02570319
PMID: 31562182
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

The number of patients dialyzed for ESKD exceeds 500,000 in the United States and more than 2.6 million people worldwide, with the expectation that the worldwide number will double by 2030. The human cost of health and societal financial cost of ESKD is substantial. Dialytic therapy is associated with an unacceptably high morbidity and mortality rate and poor quality of life. Although innovation in many areas of science has been transformative, there has been little innovation in dialysis or alternatives for kidney replacement therapy (KRT) since its introduction approximately 70 years ago. Advances in kidney biology, stem cells and kidney cell differentiation protocols, biomaterials, sensors, nano/microtechnology, sorbents and engineering, and interdisciplinary approaches and collaborations can lead to disruptive innovation. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the US Food and Drug Administration, has convened a multidisciplinary group to create a technology roadmap for innovative approaches to KRT to address patients' needs. The Roadmap is a living document. It identifies the design criteria that must be considered to replace the myriad functions of the kidney, as well as scientific, technical, regulatory, and payor milestones required to commercialize and provide patient access to KRT alternatives. Various embodiments of potential solutions are discussed, but the Roadmap is agnostic to any particular solution set. System enablers are identified, including vascular access, biomaterial development, biologic and immunologic modulation, function, and safety monitoring. Important Roadmap supporting activities include regulatory alignment and innovative financial incentives and payment pathways. The Roadmap provides estimated timelines for replacement of specific kidney functions so that approaches can be conceptualized in ways that are actionable and attract talented innovators from multiple disciplines. The Roadmap has been used to guide the selection of KidneyX prizes for innovation in KRT. Copyright © 2019 by the American Society of Nephrology.

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