Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions

Surendra Shenoy; 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

doi:10.2215/CJN.13321216

Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions

Surendra Shenoy, 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

Research output: Contribution to journal › Article › peer-review

41 Scopus citations

Original language	English
Pages (from-to)	490-494
Number of pages	5
Journal	Clinical Journal of the American Society of Nephrology
Volume	13
Issue number	3
DOIs	https://doi.org/10.2215/CJN.13321216
State	Published - Mar 7 2018

Keywords

Arteriovenous fistula
Biological Products
Clinical trial
Consensus
Humans
Polytetrafluoroethylene
Renal dialysis
Vascular

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10.2215/CJN.13321216

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Shenoy, S., Allon, M., Beathard, G., Brouwer-Maier, D., Dember, L. M., Glickman, M., Lee, C., Litchfield, T., Lok, C., Huber, T., Roy-Chaudhury, P., Work, J., West, M., & Wasse, H. (2018). Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions. Clinical Journal of the American Society of Nephrology, 13(3), 490-494. https://doi.org/10.2215/CJN.13321216

@article{c9636677d06b45399a54821eeb872a68,

title = "Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions",

keywords = "Arteriovenous fistula, Biological Products, Clinical trial, Consensus, Humans, Polytetrafluoroethylene, Renal dialysis, Vascular",

author = "Surendra Shenoy and Michael Allon and Gerald Beathard and Deborah Brouwer-Maier and Dember, {Laura M.} and Mark Glickman and Celeste Lee and Terry Litchfield and Charmaine Lok and Thomas Huber and Prabir Roy-Chaudhury and Jack Work and Melissa West and Haimanot Wasse",

note = "Funding Information: This work was supported by the Kidney Health Initiative (KHI), a public-private partnership of the American Society of Nephrology (ASN), US Food and Drug Administration, and .75 member non-for-profit and for profit organizations. KHI funds were used to defray costs, including project management costs. There was no remuneration to KHI workgroup members. The authors are fully responsible for the content of this work. KHI makes every effort to avoid actual, potential, or perceived conflicts of interest among membersoftheworkgroup.MoreinformationontheKHI,orconflict of interest policy, can be found at www.kidneyhealthinitiative.org. The views and opinions expressed in this manuscript are those of the authors and do not necessarily represent the official views or policies of any KHI member organization, or the US Department of Health and Human Services. No mention of trade names, organizations, or reference to particular technologies implies endorsement by the KHI, or any US Government Agency. Funding Information: S.S. receives research funding for Humacyte Inc. and serves on the Clinical Adjudication Committee, CR Bard. M.A. serves as a consultant for CorMedix. G.B. is an employee of Lifeline Vascular Access/DaVita. L.D. serves as a Data and Safety Monitoring Board Member of Proteon Therapeutics, Inc. M.G. has consultancy agreements with WL Gore TVA Merit Medical Proteon, ownership interest with TVA Medical, Hancock Jaffe Labs and receives honoraria from Cryolife, WL Gore, and Merit. T.L. serves as a consultant with Lifeline Vascular. C.L. receives research funding from TVA Medical, honoraria from Sanofi and InMed Pharmaceuticals. P.R.-C. serves on the Advisory Boards at Medtronic, CR Bard, WL Gore, TVA Medical and CorMedix. H.W. serves as a consultant for TVA Medical, Proteon Therapeutics, Inc., and CTI Clinical Trial Service, Inc. T.H., D.B.-M., and C.L. reported no disclosures. Funding Information: This work was supported by the Kidney Health Initiative (KHI), a public-private partnership of the American Society of Nephrology (ASN), US Food and Drug Administration, and >75 member non-for-profit and for profit organizations. KHI funds were used to defray costs, including project management costs. There was no remuneration to KHI workgroup members. The authors are fully responsible for the content of this work. KHI makes every effort to avoid actual, potential, or perceived conflicts of interest among members of the workgroup. More information on the KHI, or conflict of interest policy, can be found at www.kidneyhealthinitiative.org. The views and opinions expressed in this manuscript are those of the authors and do not necessarily represent the official views or policies of any KHI member organization, or the US Department of Health and Human Services. No mention of trade names, organizations, or reference to particular technologies implies endorsement by the KHI, or any US Government Agency.",

year = "2018",

month = mar,

day = "7",

doi = "10.2215/CJN.13321216",

language = "English",

volume = "13",

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journal = "Clinical Journal of the American Society of Nephrology",

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Shenoy, S, Allon, M, Beathard, G, Brouwer-Maier, D, Dember, LM, Glickman, M, Lee, C, Litchfield, T, Lok, C, Huber, T, Roy-Chaudhury, P, Work, J, West, M & Wasse, H 2018, 'Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions', Clinical Journal of the American Society of Nephrology, vol. 13, no. 3, pp. 490-494. https://doi.org/10.2215/CJN.13321216

TY - JOUR

T1 - Clinical trial end points for hemodialysis vascular access

T2 - Background, rationale, and definitions

AU - Shenoy, Surendra

AU - Allon, Michael

AU - Beathard, Gerald

AU - Brouwer-Maier, Deborah

AU - Dember, Laura M.

AU - Glickman, Mark

AU - Lee, Celeste

AU - Litchfield, Terry

AU - Lok, Charmaine

AU - Huber, Thomas

AU - Roy-Chaudhury, Prabir

AU - Work, Jack

AU - West, Melissa

AU - Wasse, Haimanot

N1 - Funding Information: This work was supported by the Kidney Health Initiative (KHI), a public-private partnership of the American Society of Nephrology (ASN), US Food and Drug Administration, and .75 member non-for-profit and for profit organizations. KHI funds were used to defray costs, including project management costs. There was no remuneration to KHI workgroup members. The authors are fully responsible for the content of this work. KHI makes every effort to avoid actual, potential, or perceived conflicts of interest among membersoftheworkgroup.MoreinformationontheKHI,orconflict of interest policy, can be found at www.kidneyhealthinitiative.org. The views and opinions expressed in this manuscript are those of the authors and do not necessarily represent the official views or policies of any KHI member organization, or the US Department of Health and Human Services. No mention of trade names, organizations, or reference to particular technologies implies endorsement by the KHI, or any US Government Agency. Funding Information: S.S. receives research funding for Humacyte Inc. and serves on the Clinical Adjudication Committee, CR Bard. M.A. serves as a consultant for CorMedix. G.B. is an employee of Lifeline Vascular Access/DaVita. L.D. serves as a Data and Safety Monitoring Board Member of Proteon Therapeutics, Inc. M.G. has consultancy agreements with WL Gore TVA Merit Medical Proteon, ownership interest with TVA Medical, Hancock Jaffe Labs and receives honoraria from Cryolife, WL Gore, and Merit. T.L. serves as a consultant with Lifeline Vascular. C.L. receives research funding from TVA Medical, honoraria from Sanofi and InMed Pharmaceuticals. P.R.-C. serves on the Advisory Boards at Medtronic, CR Bard, WL Gore, TVA Medical and CorMedix. H.W. serves as a consultant for TVA Medical, Proteon Therapeutics, Inc., and CTI Clinical Trial Service, Inc. T.H., D.B.-M., and C.L. reported no disclosures. Funding Information: This work was supported by the Kidney Health Initiative (KHI), a public-private partnership of the American Society of Nephrology (ASN), US Food and Drug Administration, and >75 member non-for-profit and for profit organizations. KHI funds were used to defray costs, including project management costs. There was no remuneration to KHI workgroup members. The authors are fully responsible for the content of this work. KHI makes every effort to avoid actual, potential, or perceived conflicts of interest among members of the workgroup. More information on the KHI, or conflict of interest policy, can be found at www.kidneyhealthinitiative.org. The views and opinions expressed in this manuscript are those of the authors and do not necessarily represent the official views or policies of any KHI member organization, or the US Department of Health and Human Services. No mention of trade names, organizations, or reference to particular technologies implies endorsement by the KHI, or any US Government Agency.

PY - 2018/3/7

Y1 - 2018/3/7

KW - Arteriovenous fistula

KW - Biological Products

KW - Clinical trial

KW - Consensus

KW - Humans

KW - Polytetrafluoroethylene

KW - Renal dialysis

KW - Vascular

UR - http://www.scopus.com/inward/record.url?scp=85043319737&partnerID=8YFLogxK

U2 - 10.2215/CJN.13321216

DO - 10.2215/CJN.13321216

M3 - Article

C2 - 29487092

AN - SCOPUS:85043319737

SN - 1555-9041

VL - 13

SP - 490

EP - 494

JO - Clinical Journal of the American Society of Nephrology

JF - Clinical Journal of the American Society of Nephrology

IS - 3

ER -

Clinical trial end points for hemodialysis vascular access: Background, rationale, and definitions

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