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. 2022 Sep 30;75(7):1210-1216.
doi: 10.1093/cid/ciac071.

Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials

Hannah Imlay  1 , Paul Baum  2 , Daniel C Brennan  3 , Kimberly E Hanson  1 , Michael R Hodges  4 , Aimee C Hodowanec  5 , Takashi E Komatsu  5 , Per Ljungman  6 , Veronica Miller  7 , Yoichiro Natori  8 , Volker Nickeleit  9 , Jules O'Rear  5 , Andreas Pikis  5 , Parmjeet S Randhawa  10 , Deirdre Sawinski  11 , Harsharan K Singh  9 , Gabriel Westman  12 , Ajit P Limaye  13
Affiliations

Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials

Hannah Imlay et al. Clin Infect Dis. .

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.

Keywords: BK polyomavirus; BKPyV nephropathy; end points for clinical trials; renal transplant.

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Conflict of interest statement

Potential conflicts of interest. P. B. has received salary, stock options, and support for attending meetings or travel from Roche Diagnostics. D. C. B. has received grants/research support from CareDx (to John Hopkins for research on donor-derived cell-free DNA and relation to BK infection), Natera, Amplyx Pharmaceuticals (to John Hopkins for research on BK), and AlloVir (to John Hopkins for research on BK); consulting fees from CareDx, Medeor, Natera, and Sanofi (use of donor-derived cell-free DNA); honoraria from CareDx (use of donor-derived cell-free DNA), Sanofi (Infections in Transplantation), and Veloxis; and has served on the editorial boards of Transplantation and UpToDate. M. R. H. has received salary and consulting fees from Amplyx Pharmaceuticals and consulting fees from Pfizer, Hybridize Therapeutics, and AlloVir. P. L. has participated in a contract for a clinical trial with AlloVir (planned clinical trial at institution). V. M. receives support as part of the TAVI Forum from Amplyx Pharmaceuticals, Everys Bio, Mikrogen GmbH, Merck, Quest Diagnostics, Roche, SymBio Pharmaceuticals, and Viracor. V. N. has received grants or contracts with AlloVir and is on the advisory board for Hybridize Therapeutics. P. S. R. has a leadership role (president) of the Renal Pathology Society. A. P. L. has received consulting fees and contracts with Amplyx Pharmaceuticals (grant for being site investigator for BKPyV therapy and consulting fees for providing guidance on study design for BKPyV therapies) and has received consulting fees from AlloVir (for providing guidance on study design for immune therapies for viral infectious including BKPyV). All remaining authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

References

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