KHI Current Project

Clinical Trial Design to Support Innovative Approaches to Renal Replacement Therapy

Abstract

To bring innovative treatment alternatives to people with kidney failure, innovation in clinical trial design and endpoints must keep pace with innovation in products. This project is intended to facilitate coordinated efforts between regulators and the nephrology community to streamline the clinical development pathway. The primary objectives of the project is to define terminology for future RRT products (i.e. wearable, portable, implantable, artificial kidney, etc.) and identify the most appropriate trial designs and endpoints for a variety of RRT products. This project supports the goals of the Advancing American Kidney Health initiative and extends the work of the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy (RRT).

Deliverables

A report will provide:

  • 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,
  • Inform new trial designs and clinical development approaches, such as early feasibility studies and First in Human studies, for next generation products.
The workgroup will also produce peer-reviewed publications and resources tailored for specific audiences within the community.

Timeline

The workgroup expects to publish their report by November 2020.

Workgroup

To Be Announced.