Designing Clinical Trials for Innovative RRT Products: A New KHI Project

By Zach Cahill

KHI_Logo-Horizontal-Color_0.jpgThe Advancing American Kidney Health initiative made developing an artificial kidney a national priority. The increased interest, investment, and innovation brought about by this policy highlight the need for new and improved infrastructure to facilitate innovation.

The term “artificial kidney” can have different meanings to patients, innovators, industry, regulators, and payers. This situation demonstrates the need for consistent definitions for wearable, portable, implantable, biological, and combination products. Additionally, the potential variety of innovative RRT products may mean that a “one size fits all” clinical trial model will not work. All stakeholders would benefit from clarity on the most appropriate trial design and endpoints for future products.

The Kidney Health Initiative (KHI) is extending its prior work with the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy (RRT) to evaluate clinical trial design for innovative RRT products. The new project titled “Clinical Trial Design to Support Innovative Approaches to RRT” is a collaborative effort between the US Food and Drug Administration and members of the kidney community. The final report, which KHI hopes to deliver in less than a year, will:

  • Recommend definitions for future iterations of RRT products;
  • Identify potential clinical trial endpoints for certain types of RRT products;
  • Describe best practices and gaps from existing trial designs; and
  • Inform novel trial designs and clinical development approaches, such as early feasibility studies and First in Human studies, for next generation products.


The project workgroup expects to produce peer-reviewed publications and resources tailored for specific audiences within the community. Additionally, the project workgroup will identify ways to engage the kidney community throughout the project, including stakeholder interviews, webinars, in-person meetings, and public comment periods.

Many new innovations in the kidney space, including from KidneyX’s Redesign Dialysis prize competitions, will need to be evaluated through clinical trials before they can be introduced into the marketplace. The results of this project aim to streamline the product lifecycle process and provide clarity to innovators and payors to make the artificial kidney a reality.

To learn more about this project and KHI’s other trial design and endpoints projects, please visit www.kidneyhealthinitiative.org/projects.

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Zach Cahill
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KHI_Logo-Horizontal-Color_0.jpgThe Advancing American Kidney Health initiative made developing an artificial kidney a national priority. The increased interest, investment, and innovation brought about by this policy highlight the need for new and improved infrastructure to facilitate innovation.

The term “artificial kidney” can have different meanings to patients, innovators, industry, regulators, and payers. This situation demonstrates the need for consistent definitions for wearable, portable, implantable, biological, and combination products. Additionally, the potential variety of innovative RRT products may mean that a “one size fits all” clinical trial model will not work. All stakeholders would benefit from clarity on the most appropriate trial design and endpoints for future products.

The Kidney Health Initiative (KHI) is extending its prior work with the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy (RRT) to evaluate clinical trial design for innovative RRT products. The new project titled “Clinical Trial Design to Support Innovative Approaches to RRT” is a collaborative effort between the US Food and Drug Administration and members of the kidney community. The final report, which KHI hopes to deliver in less than a year, will:

  • Recommend definitions for future iterations of RRT products;
  • Identify potential clinical trial endpoints for certain types of RRT products;
  • Describe best practices and gaps from existing trial designs; and
  • Inform novel trial designs and clinical development approaches, such as early feasibility studies and First in Human studies, for next generation products.


The project workgroup expects to produce peer-reviewed publications and resources tailored for specific audiences within the community. Additionally, the project workgroup will identify ways to engage the kidney community throughout the project, including stakeholder interviews, webinars, in-person meetings, and public comment periods.

Many new innovations in the kidney space, including from KidneyX’s Redesign Dialysis prize competitions, will need to be evaluated through clinical trials before they can be introduced into the marketplace. The results of this project aim to streamline the product lifecycle process and provide clarity to innovators and payors to make the artificial kidney a reality.

To learn more about this project and KHI’s other trial design and endpoints projects, please visit www.kidneyhealthinitiative.org/projects.

Date:
Wednesday, December 4, 2019