Evidence map›Paper›PMID 39226143›Full record

Trial reportTransplant infectious disease : an official journal of the Transplantation Society2024

A randomized, placebo-controlled, dose-escalation phase I/II multicenter trial of low-dose cidofovir for BK polyomavirus nephropathy.

Hannah Imlay, John W Gnann, James Rooney, V Ram Peddi, Alexander C Wiseman, Michelle A Josephson, Clifton Kew, Jo-Anne H Young, Deborah B Adey, Milagros Samaniego-Picota and 2 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Transplant infectious disease : an official journal of the Transplantation Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. 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
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  3. Review
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  5. Review
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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

12 authors.

Hannah ImlayDepartment of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.ORCID https://orcid.org/0000-0002-3429-4655
John W GnannDepartment of Medicine, Medical University of South Carolina University Medical Center, Charleston, South Carolina, USA.
James RooneyGilead Sciences, Foster City, California, USA.
V Ram PeddiDepartment of Transplantation, California Pacific Medical Center, San Francisco, California, USA.
Alexander C WisemanDepartment of Medicine, University of Colorado at Denver Health Sciences Center, Denver, Colorado, USA.
Michelle A JosephsonDepartment of Medicine, University of Chicago, Chicago, Illinois, USA.
Clifton KewDepartment of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Jo-Anne H YoungDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID https://orcid.org/0000-0003-4182-341X
Deborah B AdeyDepartment of Medicine, University of California at San Francisco, San Francisco, California, USA.
Milagros Samaniego-PicotaDepartment of Medicine, University of Wisconsin Medical School, Madison, Wisconsin, USA.
Richard J WhitleyDepartment of Pediatrics, University of Alabama, Birmingham, Alabama, USA.ORCID https://orcid.org/0000-0001-9959-9276
Ajit P LimayeDepartment of Internal Medicine, University of Washington, Seattle, Washington, USA.

Funding

National Institute of Allergy and Infectious Diseases AI-30025
6 · The paper itself

Abstract

backgroundBK polyomavirus-associated nephropathy (BKPyVAN) is an important cause of allograft dysfunction and failure in kidney transplant recipients (KTRs) and there are no proven effective treatments. Case reports and in vitro data support the potential activity of cidofovir against BK polyomavirus (BKPyV).

methodsWe report the results of a phase I/II, double-blind, placebo-controlled randomized dose-escalation trial of cidofovir in KTRs with biopsy-confirmed BKPyVAN and estimated glomerular filtration rate ≥30 mL/min. Intravenous cidofovir (0.25 mg/kg/dose or 0.5 mg/kg/dose) or placebo was administered on days 0, 7, 21, and 35, with final follow-up through day 49.

resultsThe trial was prematurely discontinued due to slow accrual after 22 KTRs had completed the study. Cidofovir was safe and tolerated at the doses and duration studied. The proportion of subjects with any adverse event (AE) was similar between groups (9/14 [64%] in the combined cidofovir dose groups and 6/8 [75%] in the placebo group); 84% of AEs were mild. BKPyV DNAemia reduction by day 49 was similar between groups (>1 log

conclusionsThese preliminary results indicate that low-dose cidofovir was safe and tolerated but had no significant BKPyV-specific antiviral effect in KTRs with BKPyVAN.

Indexed as

Antiviral AgentsBK VirusCidofovirKidney DiseasesKidney TransplantationPolyomavirus InfectionsTumor Virus InfectionsAdultAgedCytosineDose-Response Relationship, DrugDouble-Blind MethodFemaleGlomerular Filtration RateHumansMaleAntiviral AgentsCidofovirCytosineOrganophosphonatesBK viruscidofovirkidney transplantrandomized controlled trial

Identifiers

PMID39226143
PMCPMC11666883

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Registered trials

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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.