Welcome to KidneyX

At ASN Kidney Week 2017, Bruce D. Greenstein, U.S. Department of Health and Human Services (HHS), Chief Technology Officer, highlighted the need for innovation in the nephrology space and announced HHS' commitment to launch a Kidney Innovation Accelerator.

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What is KidneyX?

The Kidney Innovation Accelerator (KidneyX) is a public-private partnership to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. KidneyX seeks to improve the lives of the 850 million people worldwide currently affected by kidney diseases by accelerating the development of drugs, devices, biologics and other therapies across the spectrum of kidney care including:

Prevention

Diagnostics

Treatment

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Guiding KidneyX

Mission

Accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases

Principles

  • Patient-Centered Ensure all product development is patient-centered
  • Urgent Create a sense of urgency to meet the needs of people with kidney diseases
  • Achievable Ground in scientifically-driven technology development
  • Catalytic Reduce regulatory and financial risks to catalyze investment in kidney space
  • Collaborative Foster multidisciplinary collaboration including innovators throughout science and technology, the business community, patients, care partners, and other stakeholders
  • Additive Address barriers to innovation public/private sectors do not otherwise
  • Sustainable Invest in a diverse portfolio to balance risk and sustain KidneyX

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How will KidneyX Succeed?

Building off the success of similar public-private accelerators, KidneyX will engage a community of researchers, innovators, and investors to bring breakthrough therapies to patients by:

Development

Driving patient access to disruptive technologies via competitive, non-dilutive funding to innovators.

Coordination

Providing a clearer and less expensive path to bringing products to patients and their families.

Urgency

Creating a sense of urgency by spotlighting the immediate needs of patients and their families.

Get Involved

Interested in being part of the KidneyX solution? Enter your email address to join the mailing list:

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Kidney Disease Statistics

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A typical in-center hemodialysis patient spends 12 hours a week attached to a machine

Source: Report to Congressional Requesters: National Institutes of Health – Kidney Disease Research Funding and Priority Setting; United States Government Accountability Office; December 2016.

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Among patients ages 18-54 years old at the start of dialysis, 93% were classified as disabled

Source: Erickson K, et al. Employment among Patients Starting Dialysis in the United States. Clinc J. Am Soc Nephrol 13: 265-273, 2018.

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Each year, more than 100,000 Americans begin hemodialysis as a result of kidney failure

Source: United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

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40 Million adult Americans are currently classified as having chronic kidney disease

Source: Report to Congressional Requesters: National Institutes of Health – Kidney Disease Research Funding and Priority Setting; United States Government Accountability Office; December 2016.

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Every day 13 patients die waiting for a kidney transplant

Source: Mitchell K. For Transplant Patients, 'This is Your Statue of Liberty'. GW Magazine. http://magazine.gwu.edu/for-transplant-patients. Published December 2, 2016. Accessed March 2018.

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Of Stage 4 CKD patients, 48% were unaware of their severe CKD

Source: United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017.

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African-Americans are 3.5x more likely to develop kidney failure

Source: Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive Kidney Diseases. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Published December 2016. Accessed March 2018.

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Hispanics are 1.5x more likely to develop kidney failure

Source: Kidney Disease Statistics for the United States. National Institute of Diabetes and Digestive Kidney Diseases. https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Published December 2016. Accessed March 2018.

What's Next?

In preparation of launching its first prize competition on October 25, 2018, KidneyX released two Requests for Information (RFI) soliciting feedback on the KidneyX initiative more broadly and the design of the prize competition. KidneyX is committed to designing the prize competitions with input from patients and innovators so that KidneyX will be successful in:

  1. Improving quality of life for people living with kidney diseases and
  2. Supporting innovators who will develop products and tools to improve the quality of life for people living with kidney diseases.

We encourage you to read the full RFIs and submit your feedback by clicking the button below:

Read Full RFIs

The Kidney Health Initiative, a partnership between the American Society of Nephrology and the U.S. Food and Drug Administration, released a draft of the Technology Roadmap for Innovative Renal Replacement Therapy for public comment. This document outlines strategies and research pathways needed to more effectively and efficiently develop commercially viable RRT alternatives to current dialysis therapy. The Roadmap will serve as a resource for participants of KidneyX's first prize competition.

Interested stakeholders are invited to review and provide feedback on the draft roadmap below:

View KHI Roadmap

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KidneyX In The News

President's Column: Kidney Innovation Accelerator

Mark D. Okusa, MD, FASN, President of the American Society of Nephrology, catalogues the need for innovation in nephrology and the potential of KidneyX to accelerate the development and commercialization of kidney therapeutics and improve the lives of patients with kidney diseases.

February 1, 2018

Trump Administration Proposes 'Kidney Innovation Accelerator Program'

The Department of Health and Human Services (HHS) has recently taken a critical step that will hopefully increase kidney disease research and therapy integration to the level it needs to be.

December 1, 2017

HHS to Launch Initiative Encouraging Innovation in Kidney Care

The Department of Health and Human Services announced last week that it will establish a public-private fund to help move new technology forward in treating kidney disease.

November 7, 2017

KidneyX Accelerator Raises Hopes for Innovation in Kidney Space

Innovation in kidney care promises to be a significant theme in the kidney community in 2018, and it is hoped, well beyond.

January 5, 2018

Sparking Innovation to Improve the Lives of People with Kidney Disease

In February of 2017, the VA and ASN convened the inaugural Kidney Innovation Summit at the BAH Innovation Center in Washington D.C. to identify opportunities for innovation in the care of people with CKD.

September 7, 2017

VA's Kidney Innovation Summit: Seeding Opportunities for Better Health

The Kidney Innovation Summit, convened by the VA Center for Innovation and ASN, brought together over 150 great minds to think through new approaches to prevent and treat kidney disease.

February 21, 2017

Frequently Asked Questions (FAQ)

What is KidneyX?

KidneyX, also called the Kidney Innovation Accelerator, is a public-private partnership between the U.S. Department of Health and Human Services (HHS) and the American Society of Nephrology (ASN). HHS is the Federal agency whose mission is to enhance and protect the health and well-being of all Americans. The HHS divisions participating in KidneyX include the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Established in April 2018, KidneyX aims to use prize competitions to accelerate the development of innovative solutions that can prevent, diagnose, and/or treat kidney diseases. KidneyX aims to promote collaboration between patients, health professionals, innovators, industry, and government with the ultimate goal of improving quality of life for people living with kidney diseases.

KidneyX will:

1) Fund promising innovators through a series of prize competitions;

2) Encourage better coordination across the HHS agencies, including CMS, FDA, and NIH, to clarify the path toward commercialization and patient access to innovative products; and

3) Create a sense of urgency to develop new ways to prevent, diagnose, or treat kidney diseases.

What is a prize competition?

A prize competition is a method of problem-solving that describes a problem (usually to the general public) and offers a prize or prizes to whoever comes up with the best solution(s). Prize competitions are a good way to attract ideas and skills from a wide range of fields. Prize competitions only provide funding for solutions that meet the judging criteria established when the competition is announced.

How will KidneyX prize competitions work?

In its prize competitions, KidneyX will identify and describe a problem related to kidney disease that needs to be addressed (for example, finding a new class of kidney replacement therapeutic options for patients, empowering patients or designing better diagnostic tools). Each KidneyX prize competition announcement will outline that prize's eligibility rules, describe the submission process and prize, and explain the criteria for selecting winners. After the submission period ends, a panel of judges will select the winners from the submissions received.

KidneyX currently plans to run most of its prize competitions as two phase prizes. In phase 1 of these prizes, applicants will submit their ideas and solutions to the problems described. Judges will select a group of winners. That group will then participate in phase 2, in which they will build or further develop their solution. At the end of phase 2, participants who have met identified benchmarks will receive an additional cash prize.

What will the first KidneyX prize competition be, and when will it launch?

Currently, KidneyX plans to launch its first prize competition on October 25, 2018. This competition will focus on improving kidney replacement therapies for patients.

What will future KidneyX prize competitions be?

Future KidneyX prize competitions will cover a range of topics in kidney care. Possible topic areas include medications (a variety of treatments for kidney disease, including drugs and biologics), diagnostics (point-of-care or at-home testing kits, better tools to measure kidney function), patient-centered tools (electronic health record tools designed to identify and track disease, applications to empower patients to manage kidney disease), and next generation dialysis (wearable or implantable dialyzers, tissue engineering).

Does KidneyX provide grants?

KidneyX does not provide grants. Instead, KidneyX will operate a series of prize competitions (see What is a prize competition?).

How much funding will be available for prize competition winners?

The official announcement of the first KidneyX prize competition on October 25, 2018 will include information about funding levels for the first KidneyX prize.

What is the timeframe for the first KidneyX prize competition?

While this timeframe is subject to change, KidneyX intends to announce the first prize (opening the application period) on October 25, 2018. Phase 1 winners will be announced in January or February, 2019. Phase 2 of the competition will begin with the announcement of the phase 1 winners; the length of phase 2 may be 6-8 months.

What kind of solutions are you seeking for the first KidneyX prize?

The official announcement of the first KidneyX prize competition on October 25, 2018 will provide more details about this. However, for the first prize competition, KidneyX is interested in solutions that can 1) help replicate kidney functions such as blood filtration, electrolyte homeostasis, fluid regulation, or toxin removal and secretion; or 2) improve patient quality of life (e.g., increase mobility, minimize intrusion of therapy on family and social life, reduce disease and treatment complications); or 3) improved kidney replacement therapy access (vascular, peritoneal, or blood circuit access needed for treatment); or 4) strengthen safety monitoring functions.

Who can apply to participate in KidneyX?

Anyone can apply to participate in KidneyX, either as individuals or teams. Each KidneyX prize competition announcement will include the eligibility rules (if any) for that prize.

KidneyX recognizes that many potential participants may have applicable technologies, concepts, or expertise from domains that have not previously been considered with regards to kidney diseases. One of KidneyX's biggest goals is to bring such technologies and expertise into the kidney space.

What sort of help will KidneyX provide to participants?

KidneyX plans to assist prize winners in a variety of ways. Because new innovators often lack experience in product commercialization, KidneyX plans to help prize winners receive input and feedback from patients, investors, business and manufacturing experts, scientists, engineers, regulators, payers, and others as needed. Prize winners may also be eligible to receive regulatory support from the Food and Drug Administration (FDA) through existing technical assistance pathways such as FDA's Breakthrough Device Program, scientific expertise from the National Institutes for Health (NIH), and coverage and reimbursement consultation from the Centers for Medicare and Medicaid (CMS). Please note that the participation of government entities is not a guarantee of any particular regulatory result.

How can my organization support KidneyX?

KidneyX is seeking additional partners. Organizations interested in supporting KidneyX (whether by providing financial resources, scientific expertise or other means) are encouraged to contact KidneyX staff at kidneyx@asn-online.org.

How can I stay informed about KidneyX?

To receive updates on KidneyX, please sign up for our e-mail list on KidneyX.org; you can also follow KidneyX on Twitter (@Kidney_X).

How can I contact KidneyX?

You can contact KidneyX via e-mail at kidneyx@asn-online.org.

Want to Learn More?

Contact KidneyX

Individuals that are interested in being part of the KidneyX solution are encouraged to contact KidneyX at kidneyx@asn-online.org to be placed on a mailing list.

Follow on Twitter: @Kidney_X

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