U.S. and International Efforts to Help Ensure Success
In addition to the ongoing efforts to pursue the R&D activities outlined in the roadmap or develop roadmap supplements, the broader KRT community has other related initiatives.
Recent U.S. Initiatives
Kidney Innovation Accelerator (KidneyX)
KidneyX was established in 2018 as a public-private partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases through a series of prize competitions. This roadmap provides the framework that supports KidneyX's efforts to expedite the development of innovative new therapies across the spectrum of kidney care.
- Redesign Dialysis Phase 1: The inaugural competition asked innovators to accelerate the development and commercialization of next-generation dialysis products.
- Redesign Dialysis Phase 2: Further challenged participants to build and test prototype solutions, or components of solutions, that could replicate normal kidney functions or improve dialysis access.
- The Patient Innovator Challenge: Sought to improve therapeutic options and quality of life for people living with kidney diseases through ideas based on everyday experiences and ingenuity.
- COVID-19 Kidney Care Challenge: Sought solutions that could strengthen the safety and resiliency of kidney care services during the pandemic.
- The Artificial Kidney Prize builds on the Redesign Dialysis competitions with a focus on 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.
- Phase 1 award recipients provided proofs of concept and development plans for solutions that enable and advance the functionality, effectiveness, and/or reliability of artificial kidneys.
KHI Patient Reported Outcome Measures (PROM) for Novel Renal Devices Project
The US Food and Drug Administration (FDA) has recognized that patient perspectives are an essential element of medical product development. In particular, the FDA Center for Devices and Radiological Health (CDRH) has recognized the need to identify PROMs for use in clinical trials of transformative KRT devices. In 2018, KHI convened a workgroup with PRO experts, patients, industry, regulatory, and clinical representatives that developed a quality-of-life PROM conceptual framework, mapped and prioritized PROMs, and identified gaps and future needs to advance the development of meaningful PROMs for use in clinical trials of transformative KRT devices. KHI published this conceptual framework for patient reported outcomes that regulators and device developers can use to incorporate the patient perspective into the total product lifecycle.
Collection of Patient Preference Information (PPI)
As part of a 3-year contract with FDA, KHI developed a methodology to collect PPI on wearable dialysis devices. The survey examined how patients trade off the potential benefits and risks of wearable devices and how patient preferences differ based on a patient's current mode of treatment and other patient characteristics. The web-based survey of 550+ people with kidney failure was conducted in Summer 2021 through dialysis clinics and patient organizations; the results will be used as valid scientific evidence to determine the benefit-risk trade-offs patients are willing to make to accept these novel therapies.
The effort is a pilot for a larger initiative, funded by the Patient-Centered Outcomes Research Trust Fund, to build infrastructure and capacity for ongoing capture of PPI. The ultimate goal is to incorporate PPI data into a coordinated registry network (CRN) on an ongoing basis.
Much of the expertise and technology needed to develop an implantable artificial kidney likely already exists throughout the world. Achieving the vision of developing an artificial kidney will require international collaboration, cooperation, and integration of the expertise and activities of diverse stakeholders from across the globe — scientists, engineers, clinicians, patients, policymakers, investors, regulators, foundations, and many others.
The following efforts reflect progress in this direction:
- Collaboration between the Dutch Kidney Foundation (DKF) and the European Kidney Health Alliance (EKHA)
- Collaboration between the International Society for Nephrology (ISN) and the EKHA
- Collaboration among the EKHA, the DKF, and the European Renal Association — European Dialysis and Transplant Association (ERA-EDTA)
- The EKHA and the European Kidney Patient Federation (EKPF) joined the Decade of the Kidney™ established by the American Association of Kidney Patients (AAKP)
Additionally, other membership-based organizations are connecting researchers to collaborate on development of an artificial kidney:
- American Society for Artificial Internal Organs (ASAIO)
- Asia-Pacific Society for Artificial Organs (APSAO)
- European Society for Artificial Organs (ESAO)
- International Federation for Artificial Organs (IFAO)
- Japanese Society for Artificial Organs (JSAO)
This roadmap provides a framework for the coordinated development of innovative KRT solutions that can propel the industry forward and achieve the vision of improved quality of life for people receiving KRT. The strategies of the roadmap encourage multidisciplinary approaches that will necessitate attracting innovators globally from outside of the KRT, kidney, and medical fields. Connecting current researchers and developers with experts with complementary skills and insight will enable the KRT field to leverage technologies from other industries while infusing the KRT community with fresh, new ideas.
Such a disruptive shift in the KRT paradigm needs to be a worldwide effort, attracting new thinking and partners from throughout the international community. For example:
- Various geopolitical regions could agree to integrate milestones from this KRT roadmap into their individual R&D proposals.
- Good international networks of nephrology organizations and artificial organs associations already exist; if these jointly link with other disciplines, research and development can be accelerated and enhanced.36
To succeed, the world's best minds need to work together; international cooperation can help maximize chances of innovative KRT solution success.