Clinical Trial Design to Support Innovative Approaches to Renal Replacement Therapy
Overview
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 facilitated coordination between regulators and the nephrology community to streamline the clinical development pathway. The goal of the project was to define terminology for future kidney replacement therapy (KRT) products (i.e. wearable, portable, implantable, artificial kidney, etc.) and identify the most appropriate trial designs and endpoints for a variety of KRT 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 Kidney Replacement Therapy.
Deliverable
Defining Common Renal Replacement Therapy (RRT) Terminology
FDA Resources for Developers of Innovative Approaches to Renal Replacement Therapy