The KidneyX Artificial Kidney Prize is a competition to accelerate the development of artificial kidneys toward human clinical trials. 

In Phase 1, the Artificial Kidney Prize calls for component or integrated prototype solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys.

 

Patients are waiting for a breakthrough

Millions of people are waiting for a breakthrough in treatment of kidney failure.

37 million Americans and more than 850 million people worldwide live with kidney disease. Current treatment methods have not changed significantly in more than 60 years and cost the U.S. more than $100 billion per year.

Innovation is urgently needed: 13 people die each day waiting for a kidney transplant, and those on dialysis face a 40% mortality rate within the first three years of treatment. People living with kidney disease need kidney replacement therapies, either as bridges to transplantation or lifelong solutions. However, innovation is also incredibly difficult; a functioning kidney is built from over 20 different cell types that seamlessly integrate to maintain homeostasis. The Artificial Kidney Prize brings multidisciplinary innovators together to collaboratively develop solutions for replicating kidney function. Their pioneering efforts may bring new hope to millions of patients, families, and caregivers by increasing survival and restoring quality of life.

Closing the innovation gap

The Kidney Innovation Accelerator (KidneyX) is a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN).

By accelerating innovation in the prevention, diagnosis, and treatment of kidney diseases, KidneyX seeks to improve the lives of people with kidney diseases by expediting the development of drugs, devices, biologics, and other therapies across the spectrum of kidney care.

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 fourth KidneyX competition — the COVID-19 Kidney Care Challenge — launched in late 2020. For more information, visit kidneyx.org.

Shifting the paradigm in kidney health

The Artificial Kidney Prize builds on past KidneyX competitions but is distinct in its goal: to accelerate the development of continuous kidney replacement therapies that provide transformational treatment options beyond current dialysis methods.

For this competition, artificial kidneys may be wearable, implantable, bioengineered, developed as a xenotransplant or chimera organ, or other approaches not yet conceived. The competition aims to bring these artificial kidney solutions toward human clinical trials with a greater level of maturity, functionality, and potential for patient impact than is currently possible. With the Artificial Kidney Prize, HHS and ASN intend to stimulate the market for further kidney health innovation, drawing greater participation and capital. Additionally, through fostering a collaborative solver community, the competition will support the development of cross-disciplinary solutions necessary for success.

The competition will award up to $10 million. Up to $4 million in Phase 1 prizes will be distributed among up to eight Phase 1 winners, at the discretion of HHS and ASN. For Phase 2, up to $6 million in prizes will be distributed to winners at the discretion of HHS and ASN. Up to $2.5 million in prizes will be awarded by HHS over Phases 1-2; up to $7.5 million in prizes will be awarded by ASN over Phases 1-2. (See the official rules, terms, and conditions for further details.)

The Artificial Kidney Prize

Phase 1 of the competition advances innovative component or integrated solutions that replace, regenerate, or compensate for loss of kidney function. This first phase seeks demonstrated scientific and technical proofs of concept with detailed development plans.

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

Phase 1

Phase 1 is open to all eligible entrants. In Phase 1:

  • Entrants are asked to submit component or integrated prototype solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys. Entrants’ submissions will include demonstrated scientific and technical proofs of concept with detailed development plans. (See submission form for further details.)
  • Submissions opened on October 30, 2020, and closed at 4:59 p.m. ET on March 24, 2021.
  • Up to eight winners will be recommended by the judging panel according to official Phase 1 evaluation criteria. The total Phase 1 prizes of up to $4 million will be distributed among up to eight Phase 1 winners, at the discretion of HHS and ASN.
  • Technical support includes entrant resources to encourage and facilitate collaboration, navigate regulatory and commercial considerations, and incorporate patient input into solution development.
  • As part of their submissions, Phase 1 entrants agree to have brief synopses or abstracts published by the KidneyX partnership.

Phase 2

Phase 2 will be open to eligible entrants from Phase 1, as well as new eligible entrants who did not enter the first phase of the competition. In Phase 2:

  • Entrants will be asked to submit an initial integration of prototype solutions into an artificial kidney, or already integrated prototype solutions that advance development of artificial kidneys. Submissions should be supported by pre-clinical (bench or animal) or clinical data demonstrating the potential of the prototype to successfully support the reliability, effectiveness and/or functionality of wearable and/or implantable artificial kidneys. In their submission, entrants will be asked to provide justification for prototype design and to include potential partners or collaborators that would enable artificial kidney development toward human clinical trials.
  • Submissions are anticipated to open in October 2021 and close in June 2022. 
  • Winners will be recommended by the judging panel according to official Phase 2 evaluation criteria. The total Phase 2 prizes of up to $6 million will be distributed to Phase 2 winners, at the discretion of HHS and ASN.
  • Technical support will include a range of informational resources to encourage and facilitate collaboration, navigate regulatory and commercial considerations, and incorporate patient input into solution development.
  • As part of their Phase 2 submissions, entrants agree to have brief synopses or abstracts of their concepts published by the KidneyX partnership.

Potential additional phases

At the discretion of HHS and ASN, additional phases of the competition may follow Phase 2. These phases would build on the enabling solutions developed in Phases 1 and 2 of the Artificial Kidney Prize by calling for integrated, continuous artificial kidney solutions, accelerating their development, and advancing them toward human clinical trials. KidneyX hopes to secure total prizes of up to $200 million for all potential phases of the competition.

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