Clinical Trial Endpoints for Dialysis Vascular Access

Abstract

Dialysis Vascular Access is both the "Lifeline" and "Achilles Heel" for patients on hemodialysis. Despite the magnitude of the clinical problem there are currently no truly effective therapies for dialysis vascular access dysfunction. An important barrier to the development of safe and effective therapies could be the lack of consensus as to the "right" clinical trial endpoints for this condition. The current project aims to bring together the diverse stakeholders in this area (Patients, Physicians, Industry, Dialysis Organizations and Federal Agencies [FDA, CMS, NIH]) to develop a set of consensus clinical trial end points in this field.

Patient Care Issue

Hemodialysis vascular access has been called the "lifeline" for patients on hemodialysis. Unfortunately, due to the many problems associated with dialysis vascular access (stenosis, thrombosis, infection), it is also the "Achilles Heel" of hemodialysis. Specifically, more than 50% of arteriovenous fistulae (AVF) are unsuitable for hemodialysis four to five months following creation; the primary patency of arteriovenous grafts (AVG) has been reported to be as low as 23% at one year; and only 9% of tunneled dialysis catheters (TDCs) are still functional at one year.

Challenge

An important barrier to the development of safe and effective therapies could be the lack of consensus as to the "right" clinical trial endpoints for this condition.

Solution

This project convened diverse stakeholders in this area (health professionals, industry, dialysis organizations, and federal agencies) to clarify appropriate trial endpoints for vascular access trials best suited to inform clinical, regulatory, and coverage decisions, in those circumstances where clinical data is required to support the decisions.