Kidney Health Initiative (KHI)

KHI Current Project

Development of a Roadmap for Innovations in Renal Replacement Therapy (RRT)

KHI Workshop - Innovative Alternatives to Renal Replacement Therapy: Developing a Roadmap
Patient Care Issue

There has been little change in the basic construct of dialysis technology over the past 50 years. This lack of innovation contributes to the substantial morbidity, mortality, poor quality of life and costs associated with dialysis. There has been little focus on the development of new generation renal replacement therapy (RRT) devices that target the issues that are important to patients--- time spent in dialysis, intrusion into their life, low energy and restrictions on travel and work.

Challenge

Advances in RRT have not matched technological developments in other areas, i.e. insulin pumps, pharmacogenomics, computers, cell phones

  • Dialysis is intrusive to the patient and impacts their autonomy and quality of life
  • Maintaining vascular access remains a problem
  • Knowledge gaps exist in basic kidney science, ie biomarkers, cellular functions
KHI Solution

KHI has initiated this project to identify the scientific, technical, and regulatory milestones needed to achieve the goal of creating a bioengineered alternative to dialysis as renal replacement therapy. The approach will be to:

  • Convene a diverse group of stakeholders, patients and care partners, academics, industry and regulators.
  • Describe scientific, technical, reimbursement, and regulatory challenges for mechanical, cellular and hybrid technologies.
  • Create a set of design criteria for future alternatives to RRT.
  • Identify ways to incorporate patient preferences and feedback on design features.
  • Create a roadmap with milestones and opportunities for creating a bioengineered alternative to dialysis.
Status

Workgroups have been established and are developing patient-centered design criteria and R&D solution areas. The first draft is expected in May, 2018 with a final roadmap in August, 2018.

Deliverable

Document that communicates the renal replacement field's current challenges and barriers, product design criteria, and priority R&D activities.

Timeframe for Completion

August, 2018

STEERING COMMITTEE

Chair: Joseph V. Bonventre, MD PhD

Brigham and Women's Hospital and Harvard Medical School

Gema Gonzalez, PhD

Center for Devices and Radiological Health (CDRH), FDA

Frank Hurst, MD

Center for Devices and Radiological Health (CDRH), FDA

Carolyn Y. Neuland, PhD

Center for Devices and Radiological Health (CDRH), FDA

Laura Ricles, PhD

Center for Biologics Evaluation and Research, FDA

Prabir Roy-Chaudhry, MD, PhD, FASN

University of Arizona and the Southern Arizona VA Healthcare System

Murray Sheldon, MD

Center for Devices and Radiological Health (CDRH), FDA

Douglas M. Silverstein, MD

Center for Devices and Radiological Health (CDRH), FDA

David M. White

Patient, Healthcare Consultant

Iwen Wu, PhD

Center for Biologics Evaluation and Research, FDA

Carolyn Yong, PhD

Center for Biologics Evaluation and Research, FDA