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Enrolling by invitationNCT05224583Updated Mar 20, 2026

Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

An observational study in Polyomavirus Infections, BK Viremia and Liver Transplant Infection, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Methodist Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%.

Read the detailed description

The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%. Immunosuppression reduction is the management cornerstone for BKV and has been shown to be effective at clearing the virus while maintaining graft function in both kidney alone and simultaneous kidney-pancreas transplant recipients. However, there is a lack of published data on the prevalence and outcomes in simultaneous liver-kidney (SLK) transplant recipients.

02

Conditions studied

  • Polyomavirus Infections
  • BK Viremia
  • Liver Transplant Infection
  • Kidney Transplant Infection
03

In context

Lead sponsor

Methodist Health System is the lead sponsor of 170 studies on the registry; 50 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • SLK recipients transplanted at MDMC between 2015-2020

Exclusion criteria

Exclusion Criteria:

  • Below 18 years of age
  • Patients who did not undergo SLK transplant at MDMC
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Simultaneous Liver-Kidney Transplant patients population at MDMC

    Consecutive SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020).

    Procedure: Simultaneous Liver-Kidney Transplant

Interventions

  • ProcedureSimultaneous Liver-Kidney Transplant

    Simultaneous Liver-Kidney Transplant

06

What researchers measure

Primary outcomes

  1. To characterize the prevalence of BKV in the SLK patient population at (Methodist Dallas Medical Center)MDMC.

    number of SLK transplant recipients who were transplanted at (Methodist Dallas Medical Center)MDMC

    Time frame: over a 6-year period (2015 to 2020).

07

Study locations

1 site
08

References and documents

Publications

  • Kotton CN, Kamar N, Wojciechowski D, Eder M, Hopfer H, Randhawa P, Sester M, Comoli P, Tedesco Silva H, Knoll G, Brennan DC, Trofe-Clark J, Pape L, Axelrod D, Kiberd B, Wong G, Hirsch HH; Transplantation Society International BK Polyomavirus Consensus Group. The Second International Consensus Guidelines on the Management of BK Polyomavirus in Kidney Transplantation. Transplantation. 2024 Sep 1;108(9):1834-1866. doi: 10.1097/TP.0000000000004976. Epub 2024 Apr 12. PubMed 38605438 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2021 (actual). Primary completion is estimated for Nov 2027, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 3, 2022
First posted
Feb 4, 2022
StartActual
Nov 17, 2021
Primary completionEst.
Nov 17, 2027
CompletionEst.
Nov 17, 2028
Last update
Mar 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05224583
Lead sponsor
Methodist Health System
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Nov 17, 2021
Primary completion
Nov 17, 2027 (estimated)
Completion
Nov 17, 2028 (estimated)
Last update
Mar 20, 2026

Study contacts

Lori Kautzman, MD
principal investigator · Methodist Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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