Entrant resources provide an overview of the state of kidney health and innovation as well as a primer on navigating regulatory details and incorporating patient point of view in early-stage development.

KidneyX

To date, KidneyX has completed three competitions: the Patient Innovator Challenge and Redesign Dialysis Phase 1 and Phase 2. These competitions sought to improve the quality of life for people with kidney failure by improving current dialysis treatment through innovations that reduce infection risk, improve vascular access, and replace kidney functions.

KidneyX has awarded over $4 million to winners of these competitions. A forthcoming KidneyX competition — the COVID-19 Kidney Care Challenge — will begin accepting submissions on November 6. For more information, visit kidneyx.org.

Phase 1 priority solution areas

In Phase 1 of the competition, integrated solutions are encouraged, but other innovative and impactful approaches that replace or regenerate kidney function, or compensate for loss of kidney function, will also be considered.

Entrants should refer to the Kidney Health Initiative’s 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy described in the challenge announcement for baseline design criteria. Proposed solutions should meet these requirements for any of the outlined options of an artificial kidney (e.g., wearable, implantable). General areas of interest include:

  • Continuous blood filtration with size-selective, non-clotting or non-fouling filters.
  • Continuous fluid and volume regulation assessment and automation.
  • Biologic solutions (as described in the KHI Technology Roadmap for Innovative Approaches to Renal Replacement Therapy) that address the uremic state in order to reduce frequency or substantively delay the need for dialysis.
  • Size optimization and/or miniaturization to increase patient usability.
  • Solutions that enable integration of cellular and mechanical components.
  • Solutions that enhance the scalability and/or functional potential of regenerative technologies.
  • Novel xenotransplant or chimera-based approaches.
  • Sensors for diagnostic, volume management, and cellular component uses, or for real-time monitoring and feedback loops that enhance patient functionality and safety.
  • Vascular access and drainage constructs that successfully allow for miniaturization and low-flow systems, which integrate seamlessly with artificial kidney approaches.
  • Other disruptive solutions, using approaches not specified above.

Physiological kidney functions

To mimic the natural kidney, future artificial kidneys will need to integrate a spectrum of core functions from a wide variety of scientific and engineering disciplines into one system. The Kidney Health Initiative’s 2018 Technology Roadmap for Innovative Approaches to Renal Replacement Therapy describes some of the specific scientific advances that urgently need to be addressed to realize a functioning artificial kidney, including:

  • Blood filtration: filtering blood to remove waste and excess fluid.
  • Electrolyte homeostasis: maintaining appropriate levels of key minerals in the blood.
  • Fluid regulation: regulating the amount of and/or removing excess fluid.
  • Toxin removal and secretion: removing, limiting, or preventing toxins in the bloodstream.
  • Filtrate transport and drainage: removing excess filtrate after processing; connectivity issues for filtration, processing, and exterior drainage.

The Technology Roadmap further describes “system enablers” or technological approaches to perform these functions using expertise from a combination of cellular, molecular, materials, electronic, and other scientific and engineering disciplines. System enablers cited in the Technology Roadmap include:

  • Renal replacement therapy access (vascular, peritoneal dialysis, blood circuit).
  • Biomaterials development.
  • Biological and immunological modulation.
  • Function and safety monitoring.
  • Other technologies.

Kidney technology and innovation

Kidney Health Initiative (KHI) Technology Roadmap for Innovative Approaches to Renal Replacement Therapy.
An overview of the desired future state resulting from innovative renal replacement therapy solutions, a description of technical and market challenges, and a prioritization of research activities with the greatest potential to drive the field forward. A patient edition is also available for reference.

KHI Fostering Innovations in Fluid Management Report.
A report documenting guidance for innovators developing new or enhanced devices or techniques for fluid management.

U.S. Presidential Executive Order on Advancing American Kidney Health.
The full text of the executive order issued July 2019. Section 6 calls for the development of an artificial kidney.

Regulatory navigation

Center for Devices and Radiological Health (CDRH) Learn.
An educational tool with learning modules describing regulations for medical device and radiation emitting products.

Center for Biologics Evaluation and Research (CBER) Advanced Technologies Team (CATT).
An overview of the CATT program purpose and scope, and a description of the process for interaction.

Clinical Trials for Medical Devices: FDA and the Investigational Device Exemption (IDE) process.
A presentation on clinical trials for medical devices and the IDE process through FDA.

FDA Breakthrough Devices Program.
FAQs related to the FDA breakthrough program including core benefits, eligibility, and guidance.

FDA Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) Forum.
An overview of the purpose and process for INTERACT meetings, which are informal non-binding consultations with the CBER at FDA.

Kidney Health Initiative (KHI) Guide to Regulatory Resources for the Product Developer.
A resource guide to increase the awareness and understanding of FDA Centers and the products they review; communication mechanisms that enable developers to obtain advice from the FDA; and available programs intended to facilitate development and review of eligible renal replacement therapy products.

KHI Clinical Trial Design Resources.
A series of resources on clinical trial design in the context of kidney health.

Sign up for the virtual information session.