Evidence map›Paper›PMID 35100619›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

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

Hannah Imlay, Paul Baum, Daniel C Brennan, Kimberly E Hanson, Michael R Hodges, Aimee C Hodowanec, Takashi E Komatsu, Per Ljungman, Veronica Miller, Yoichiro Natori and 8 more

Open access · greenAbstract readConsensus Statement
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. A randomized, placebo-controlled, dose-escalation phase I/II multicenter trial of low-dose cidofovir for BK polyomavirus nephropathy.Transplant infectious disease : an official journal of the Transplantation Society · 2024
    Trial
  3. Article
  4. Urinary VP1 Flow Cytometry as a Complementary Approach for BK Polyomavirus Monitoring: A Proof-Of-Concept Study.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Observational
  5. Article
  6. Article
  7. BK Polyomavirus-associated nephropathy - diagnostic and treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. A multicenter prospective study to define the natural history of BK viral infections in kidney transplantation.Transplant infectious disease : an official journal of the Transplantation Society · 2024
    Observational
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

Hannah ImlayDepartment of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
Paul BaumRoche Molecular Diagnostics, San Francisco, California, USA.
Daniel C BrennanJohns Hopkins Comprehensive Medical Center, Baltimore, Maryland, USA.
Kimberly E HansonDepartment of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
Michael R HodgesRNA Medicines, San Diego, California, USA.
Aimee C HodowanecUS Food and Drug Administration, Silver Spring, Maryland, USA.
Takashi E KomatsuUS Food and Drug Administration, Silver Spring, Maryland, USA.
Per LjungmanKarolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Veronica MillerThe Forum for Collaborative Research, Washington DC, USA.
Yoichiro NatoriDepartment of Medicine, University of Miami Miller School of Medicine/Miami Transplant Institute, Miami, Florida, USA.ORCID 0000-0002-4938-125X
Volker NickeleitDepartment of Pathology & Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Jules O'RearUS Food and Drug Administration, Silver Spring, Maryland, USA.
Andreas PikisUS Food and Drug Administration, Silver Spring, Maryland, USA.
Parmjeet S RandhawaDepartment of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Deirdre SawinskiDepartment of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Harsharan K SinghDepartment of Pathology & Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Gabriel WestmanSwedish Medical Products Agency, Uppsala University, Uppsala, Sweden.
Ajit P LimayeDepartment of Medicine, University of Washington, Seattle, Washington, USA.
United States Food and Drug Administration · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · USJohns Hopkins University · USKarolinska University Hospital · SERoche (United States) · USUniversity of Miami · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · USUniversity of Washington · USUppsala University · SE

Funding

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant candidates (COLT)U01AI163090 · NIAID · UNIVERSITY OF WASHINGTON · PI Don J Diamond, Cynthia E Fisher · 2021 to 2026
$17.4M
National Institute of Allergy and Infectious Diseases HL147011NIAID NIH HHS U01 AI163090
6 · The paper itself

Abstract

backgroundBK 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.

methodsTo 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.

conclusionsThese 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.

Indexed as

BK VirusKidney DiseasesKidney TransplantationPolyomavirus InfectionsClinical Trials as TopicHumansTransplant RecipientsBK polyomavirusBKPyV nephropathyend points for clinical trialsrenal transplant

Identifiers

PMID35100619
PMCPMC9525067
OpenAlexW4210597453

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.