Kidney Health Initiative (KHI)

KHI Current Project

Clinical Trial Endpoints for Dialysis Vascular Access

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.

KHI Solution:

This project convenes the 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.

Status:

The workgroup’s three content development teams drafted the project’s white papers. The co-chairs are finalizing the definitions that will be used across the three papers. A final template for the white papers needs to be determined before the draft content can be update and prepared for submission.

Deliverable:

Three parallel white papers on catheters, fistulas, and grafts endpoints.

Timeframe for Completion

Fall 2016.

Workgroup:
Core Committee:

Haimanot (Monnie) Wasse, MD, MPH, FASN (Workgroup Co-chair)
Northwestern University Feinberg School of Medicine

Surendra Shenoy, MD, PhD (Workgroup Co-chair)
Washington University School of Medicine, Barnes Jewish Hospital

Paul Chandeysson, MD
Center for Devices and Radiological Health (CDRH), FDA

Laura M. Dember, MD
Hospital of the University of Pennsylvania

Prabir Roy-Chaudhury, MD, PhD, FASN (ASN Co-Chair Kidney Health Initiative)
University of Arizona

Douglas M. Silverstein, MD
Center for Devices and Radiological Health (CDRH), FDA

Aliza Thompson, MD
Center for Drug Evaluation and Research (CDER), FDA

Jack Work, MD
Asheville, NC


Steering Committee:

Michael Allon, MD
University of Alabama at Birmingham

Lynda K. Ball, CNN
HSAG: ESRD Network 13
Liaison for American Nephrology Nurses' Association

Gerald A. Beathard, MD, PhD, FASN
University of Texas Medical Branch

Deborah J. Brouwer-Maier, RN, CNN
Fresenius Medical Care

Steven K. Burke, MD
Proteon Therapeutics

Deepa H. Chand, MD, FASN
Liaison for: American Society of Pediatric Nephrology

Dirk M. Hentschel, MD, FASN
Liaison for: Vascular Access Society of the Americas

Thomas S. Huber, MD, PhD
Liaison for: Society for Vascular Surgery

Paul Kravitz
Liaison for NxStage Medical Inc.

Mahesh Krishnan, MD, MPH, MBA, FASN (KHI Board of Directors Member)
Liaison for: DaVita Healthcare Partners

Jeffery Lawson, MD, PhD
Humacyte, Inc.

Charmaine E. Lok, MD
Toronto General Hospital

Gordon McLennan, MD
Liaison for: Society of Interventional Radiology

Ronald L. Pisoni, PhD
Arbor Research Collaborative for Health

Aris Q. Urbanes, MD
Lifeline Vascular Access


International Advisers:

Eric S. Chemla
London, United Kingdom

Maurizio Gallieni, MD, FASN
Milano, Italy
Liaison for: Vascular Access Society

William G. Herrington
Oxford, United Kingdom
Liaison for: University of Oxford

Kevan Polkinghorne, PhD, MBChB
Melbourne, Victoria, Austalia
Liaison for: Monash University

Miguel C. Riella, MD, PhD
Parana, Curitiba, Brazil
Liaison for: International Federation of Kidney Foundations

Jan Tordoir, MD, PhD
Maastricht, Netherlands
Liaison for: Vascular Access Society


Catheter Content Development Team:

Michael Allon, MD (Team Co-chair)
University of Alabama

Deborah J. Brouwer-Maier, RN, CNN (Team Co-chair)
Fresenius Medical Care

Kenneth Abreo, MD
Louisiana State University Health Sciences

Kevin M. Baskin, MD
University of Pittsburgh

Kay Bregel, RN, CNN
NxStage, Inc.

Andrea M. Easom, MA, MNSc, ARPN, FNP-BC, CNN-NP
University of Arkansas for Medical Sciences

Michele H. Mokrzycki, MD, MS
Montefiore Medical Center


Fistula Content Development Team:

Gerald A. Beathard, MD, PhD, FASN (Team Co-chair)
University of Texas Medical Branch

Thomas S. Huber, MD, PhD (Team Co-chair)
University of Florida
Liaison for: Society of Vascular Surgery

Donna Bednarski, MSN, RN, ANP-BC, CNN, CNP
Harper University Hospital

Jeffery Lawson
Humacyte, Inc.

Timmy C. Lee, MD, FASN
University of Alabama at Birmingham

Scott O. Trerotola, MD
Hospital of the University of Pennsylvania

Margo Underwood
C.R. Bard

Karen Woo, MD, MS
University of Southern California


Graft Content Development Team:

Charmaine E. Lok, MD (Team Co-chair)
Toronto General Hospital

Marc H. Glickman, MD, FACS (Team Co-chair)
Sentara Vascular Specialists

Ahmed Al-Jaishi, BSc-MSCI, MSc
London Health Sciences Center

David Cull, MD
University of South Carolina

Vandana D. Niyyar, MD
Emory University

Donna C. Syracuse, RN
Cryolife

Theodore H. Yuo, MD, MSc
University of Pittsburgh


Conflict of Interest

To view KHI's Conflict of Interest and Disclosure Policy please click here.

To view the Workgroup's Disclosures, please click here.