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). The group published two manuscripts.