Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Mar 7;13(3):490-494.
doi: 10.2215/CJN.13321216. Epub 2018 Feb 27.

Clinical Trial End Points for Hemodialysis Vascular Access: Background, Rationale, and Definitions

Surendra Shenoy  1 , Michael Allon, Gerald Beathard, Deborah Brouwer-Maier, Laura M Dember, Mark Glickman, Celeste Lee, Terry Litchfield, Charmaine Lok, Thomas Huber, Prabir Roy-Chaudhury, Jack Work, Melissa West, Haimanot Wasse
Affiliations

Clinical Trial End Points for Hemodialysis Vascular Access: Background, Rationale, and Definitions

Surendra Shenoy et al. Clin J Am Soc Nephrol. .
No abstract available

Keywords: Biological Products; Consensus; Humans; Polytetrafluoroethylene; arteriovenous fistula; clinical trial; renal dialysis; vascular.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Organizational structure of the kidney Health Initiative: Vascular access clinical trial endpoints project. Strategic and operational components, the three content development teams (CDTs) opportunity for regulatory feedback and patient perspectives. AVF, arteriovenous fistula; AVG, Arteriovenous graft.
Figure 2.
Figure 2.
Temporal vascular access patency definitions. The upper panel describes patency definitions after placement of the primary access, whereas the lower panel does the same after an intervention (please review in conjunction with Table 1).
See this image and copyright information in PMC

References

    1. Archdeacon P, Shaffer RN, Winkelmayer WC, Falk RJ, Roy-Chaudhury P: Fostering innovation, advancing patient safety: The kidney health initiative. Clin J Am Soc Nephrol 8: 1609–1617, 2013 - PMC - PubMed
    1. Linde PG, Archdeacon P, Breyer MD, Ibrahim T, Inrig JK, Kewalramani R, Lee CC, Neuland CY, Roy-Chaudhury P, Sloand JA, Meyer R, Smith KA, Snook J, West M, Falk RJ: Overcoming barriers in kidney health-forging a platform for innovation. J Am Soc Nephrol 27: 1902–1910, 2016 - PMC - PubMed
    1. Beathard GA, Lok CE, Glickman MH, Al-Jaishi AA, Bednarski D, Cull DL, Lawson JH, Lee TC, Niyyar VD, Syracuse D, Trerotola SO, Roy-Chaudhury P, Shenoy S, Underwood M, Wasse M, Woo K, Yuo TH, Huber TS: Definitions and end points for interventional studies for arteriovenous dialysis access [published online ahead of print July 20, 2017]. Clin J Am Soc Nephrol doi:10.2215/CJN.11531116. - PMC - PubMed
    1. Allon M, Brouwer-Meir DJ, Abreo K, Baskin KM, Bregel K, Chand DH, Easom AM, Mermel L, Mokrzycki MH, Patel PR, Roy-Chaudhury P, Shenoy S, Valentini RP, Wasse H: Recommended clinical trial end points for dialysis catheters [published online ahead of print July 20, 2017]. Clin J Am Soc Nephrol doi:10.2215/CJN.12011116. - PMC - PubMed
    1. Hurst FP, Lee RE, Thompson AM, Pullin BD, Silverstein DM: FDA regulatory perspectives for studies on hemodialysis vascular access [published online ahead of print July 24, 2017]. Clin J Am Soc Nephrol doi:10.2215/CJN.02900317. - PMC - PubMed

Publication types

MeSH terms