Hannah Imlay1, Paul Baum2, Daniel C Brennan3, Kimberly E Hanson1, Michael R Hodges4, Aimee C Hodowanec5, Takashi E Komatsu5, Per Ljungman6, Veronica Miller7, Yoichiro Natori8, Volker Nickeleit9, Jules O'Rear5, Andreas Pikis5, Parmjeet S Randhawa10, Deirdre Sawinski11, Harsharan K Singh9, Gabriel Westman12, Ajit P Limaye13. 1. Department of Internal Medicine, University of Utah, Salt Lake City, Utah, USA. 2. Roche Molecular Diagnostics, San Francisco, California, USA. 3. Johns Hopkins Comprehensive Medical Center, Baltimore, Maryland, USA. 4. RNA Medicines, San Diego, California, USA. 5. US Food and Drug Administration, Silver Spring, Maryland, USA. 6. Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden. 7. The Forum for Collaborative Research, Washington DC, USA. 8. Department of Medicine, University of Miami Miller School of Medicine/Miami Transplant Institute, Miami, Florida, USA. 9. Department of Pathology & Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA. 10. Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 11. Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 12. Swedish Medical Products Agency, Uppsala University, Uppsala, Sweden. 13. Department of Medicine, University of Washington, Seattle, Washington, USA.
Abstract
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.
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.
Authors: T D Barton; E A Blumberg; A Doyle; V N Ahya; J M Ferrenberg; S C Brozena; A P Limaye Journal: Transpl Infect Dis Date: 2006-06 Impact factor: 2.228
Authors: Volker Nickeleit; Harsharan K Singh; Parmjeet Randhawa; Cinthia B Drachenberg; Ramneesh Bhatnagar; Erika Bracamonte; Anthony Chang; W James Chon; Darshana Dadhania; Vicki G Davis; Helmut Hopfer; Michael J Mihatsch; John C Papadimitriou; Stefan Schaub; Michael B Stokes; Mohammad F Tungekar; Surya V Seshan Journal: J Am Soc Nephrol Date: 2017-12-26 Impact factor: 10.121