Clinical Trial Endpoints for Dialysis Vascular Access
Overview
This project convened diverse stakeholders (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. The Kidney Health Initiative working group developed parallel manuscripts on catheters, fistulas, and grafts endpoints.
Deliverable
- Clinical Trial End Points for Hemodialysis Vascular Access: Background, Rationale, and Definitions
- FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access
- Recommended Clinical Trial End Points for Dialysis Catheters
- Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access