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Consensus Definitio...
Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials
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- Imlay, Hannah (författare)
- Univ Utah, Dept Internal Med, Salt Lake City, UT 84132 USA.
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- Baum, Paul (författare)
- Roche Mol Diagnost, San Francisco, CA USA.
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- Brennan, Daniel C. (författare)
- Johns Hopkins Comprehens Med Ctr, Baltimore, MD USA.
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visa fler...
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- Hanson, Kimberly E. (författare)
- Univ Utah, Dept Internal Med, Salt Lake City, UT 84132 USA.
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- Hodges, Michael R. (författare)
- RNA Med, San Diego, CA USA.
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- Hodowanec, Aimee C. (författare)
- US FDA, Silver Spring, MD USA.
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- Komatsu, Takashi E. (författare)
- US FDA, Silver Spring, MD USA.
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- Ljungman, Per (författare)
- Karolinska Institutet
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- Miller, Veronica (författare)
- Forum Collaborat Res, Washington, DC USA.
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- Natori, Yoichiro (författare)
- Univ Miami, Miller Sch Med, Miami Transplant Inst, Miami, FL 33136 USA.
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- Nickeleit, Volker (författare)
- Univ N Carolina, Sch Med, Chapel Hill, NC 27515 USA.
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- O'Rear, Jules (författare)
- US FDA, Silver Spring, MD USA.
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- Pikis, Andreas (författare)
- US FDA, Silver Spring, MD USA.
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- Randhawa, Parmjeet S. (författare)
- Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA.
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- Sawinski, Deirdre (författare)
- Univ Penn, Dept Med, Philadelphia, PA 19104 USA.
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- Singh, Harsharan K. (författare)
- Univ N Carolina, Sch Med, Chapel Hill, NC 27515 USA.
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- Westman, Gabriel, 1977- (författare)
- Uppsala universitet,Institutionen för immunologi, genetik och patologi,Infektionsmedicin
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- Limaye, Ajit P. (författare)
- Univ Washington, Dept Med, Seattle, WA USA.
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Univ Utah, Dept Internal Med, Salt Lake City, UT 84132 USA Roche Mol Diagnost, San Francisco, CA USA. (creator_code:org_t)
- 2022-02-01
- 2022
- Engelska.
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Ingår i: Clinical Infectious Diseases. - : Oxford University Press (OUP). - 1058-4838 .- 1537-6591. ; 75:7, s. 1210-1216
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Background BK polyomavirus (BKPyV) infection and BK polyomavirus nephropathy (BKPyVAN) are important causes of allograft dysfunction and premature allograft loss in renal transplant recipients. Results and Discussion Controlled clinical trials to evaluate new agents for prevention and treatment are needed but are hampered by the lack of outcome measures that accurately assess the effect of the intervention, are clinically relevant, and are acceptable from a regulatory perspective. Methods To facilitate consistent end points in clinical trials and to support clinical research and drug development, definitions of BKPyV infection and disease have been developed by the BK Disease Definitions Working Group of the Transplantation Associated Virus Infection Forum with the Forum for Collaborative Research, which consists of scientists, clinicians, regulators, and industry representatives. Conclusions These definitions refine established principles of "proven" BKPyV disease and introduce a "probable" disease category that could be used in clinical trials to prevent or treat BKPyVAN in renal transplant recipients. Standardized BK polyomavirus nephropathy (BKPyVAN) definitions are needed to evaluate therapeutics. We refine established criteria for "proven" BKPyVAN and introduce a "probable disease" category based on allograft dysfunction and plasma DNAemia. Plasma DNAemia thresholds for BKPyVAN are needed.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
Nyckelord
- BK polyomavirus
- BKPyV nephropathy
- renal transplant
- end points for clinical trials
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- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Imlay, Hannah
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Baum, Paul
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Brennan, Daniel ...
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Hanson, Kimberly ...
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Hodges, Michael ...
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Hodowanec, Aimee ...
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visa fler...
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Komatsu, Takashi ...
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Ljungman, Per
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Miller, Veronica
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Natori, Yoichiro
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Nickeleit, Volke ...
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O'Rear, Jules
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Pikis, Andreas
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Randhawa, Parmje ...
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Sawinski, Deirdr ...
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Singh, Harsharan ...
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Westman, Gabriel ...
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Limaye, Ajit P.
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visa färre...
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Clinical Infecti ...
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Uppsala universitet
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Karolinska Institutet