Technology Roadmap Outlines Future Research Approaches

Many areas of medicine have seen great leaps in innovative therapies in recent years, but treatment for kidney disease has scarcely changed since the introduction of dialysis some 60 years ago.

ASN’s Kidney Health Initiative responded to this perceived lag by pushing toward a new treatment paradigm in its “Technology Roadmap for Innovative Approaches to Renal Replacement Therapy.”

“This roadmap identifies challenges and opportunities and encourages diversity of thought and attraction of expertise from various scientific and engineering communities,” according to Joseph V. Bonventre, MD, PhD, of Brigham and Women’s Hospital and Harvard Medical School in Boston. Bonventre led a multidisciplinary team that included healthcare clinicians and researchers, patients, industry partners, product developers, payers, and federal agencies during a two-year development process. The roadmap was introduced at ASN Kidney Week 2018.

The roadmap tries to break down the tasks that could lead to this paradigm shift in a way that “will help to bring innovators from various fields into the kidney space with new ideas, out-of-the-box approaches, and substantive financial resources from corporate, philanthropic, and venture capital communities,” Bonventre said.

Potential prize applicants to the Kidney Innovation Accelerator, KidneyX, a public-private partnership between the ASN and the US Department of Health and Human Services, are urged to read the roadmap as they consider their projects.

Multiple solution pathways

Because it can’t be known which approaches or research areas will bear the most fruit, the roadmap calls for exploring “multiple solution pathways” to “allow technologies and advances to be developed in parallel, rather than sequentially, offering greater opportunities to move toward more effective RRT and improved patient quality of life.”

Within these “multiple solution pathways,” the roadmap tries to progressively break down tasks into discrete pieces that researchers can independently take on and that might attract people from other fields—while trying to simultaneously move toward both short-term improvements to patient experience and longer-term innovations. It categorizes four “solution approaches”—enhanced dialysis, portable/wearable technologies, implantable/biohybrid technologies, and a regenerated kidney—and specifies goals for each approach. For example, the goals for the implantable/biohydrid approach are to:

  • Develop products that closely mimic normal physiology,
  • Develop suitable organs for transplantation (e.g., xenotransplantation, chimeras), and
  • Develop a bioengineered kidney.

The roadmap then becomes even more specific with a section that provides the “design requirements for ensured success” for the “function/components” of RRT access, blood filtration, electrolyte hemostasis, fluid regulation, toxin removal/secretion, and filtrate transport and drainage.

For each of these components, the roadmap provides specifications for “minimum technical design requirements.” For example, under blood filtration, it specifies the ability to generate a filtrate of at least 40 liters per day. (See Table 1 for more examples.)


Enabling change

The next section of the report, titled “Enabling change through focused research and design,” identifies ever-more-specific nuggets of information that can be put together independently to advance toward the overall goals.

“We dive very deep in our detail,” said Prabir Roy-Chaudhury, MD, PhD, of the University of Arizona and the Southern Arizona VA Healthcare System in Tucson and another member of the roadmap task force. “For all of the different domains that we call system enablers, there are questions to address, such as: how do you develop the right vascular access, how do you get the right biomaterials, how do you develop the right sorts of cells that may need to go onto these devices, how do you miniaturize things, how do you monitor things, and how do you quality control things.” The activities are also assigned a timeframe—near-term to long-term—for achieving them (Table 1).

“[These kinds of tasks] could be tackled by individuals who may not know anything about the kidney” but have applicable expertise, Bonventre said. “We are hoping to draw people into the field to work on these programs.”

“My dream would be that there is a little company out there that has perfected a way of filtering seawater, and if we get word out to them of this opportunity, that small company with a great idea could come into the filtration business, not for seawater, but could develop better filters for blood,” Roy-Chaudhury said. “We don’t know the direction that new technology that we want to get developed will go.”

Cancer treatment is being transformed by immunotherapy’s approach of unmasking cancer’s ability to hide from the immune system. It’s an emerging paradigm shift from chemotherapy’s approach of attacking the body’s fastest growing cells to switching on the body’s own immune system—could nephrology find a similar shift to a completely different approach?

“We have tried to be quite agnostic in defining the way the solution should look. We focused on design criteria and incorporated some ideas about directions, but we really didn’t want to be prescriptive because we don’t want to hold back any kind of innovation. For example, the replacement product doesn’t have to look anything like a kidney,” Bonventre said.

Directions of future research

In choosing the direction of their endeavors, researchers could benefit from examining the roadmap because it will likely be used in choosing which projects will receive grants and funding.

The roadmap notes: “One key near-term funding opportunity is the newly established Kidney Innovation Accelerator (KidneyX). . . .The research priorities in this roadmap offer a strategic development and implementation pathway to support KidneyX’s emphasis on expediting the development of innovative new therapies across the spectrum of kidney care.”

Applications for the first step in this funding, the KidneyX: Redesign Dialysis prize challenge, closed February 28, 2019. The $2.6 million prize competition sought “proposals for solutions or components of solutions that offer patients significant alternatives to dialysis as it is generally practiced today,” according to the prize announcement. KidneyX: Redesign Dialysis Phase 1 awardees will be announced by April 30, 2019.

KidneyX Phase 2 will begin April 15, 2019.

“We want to get this roadmap out into schools of engineering and medicine. We want to publish information in different types of journals—nephrology, medicine, engineering—and use social media extensively,” Roy-Chaudhury concludes. “We hope that the presence of a roadmap will bring in funding and investment from different sources, both public and private.”

March 2019 (Vol. 11, Number 3)