Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

March 18, 2026 updated by: Methodist Health System

Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant Recipients: A Retrospective Single-Center Review

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%.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Simultaneous Liver-Kidney Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the prevalence of BKV in the SLK patient population at (Methodist Dallas Medical Center)MDMC.
Time Frame: over a 6-year period (2015 to 2020).
number of SLK transplant recipients who were transplanted at (Methodist Dallas Medical Center)MDMC
over a 6-year period (2015 to 2020).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lori Kautzman, MD, Methodist Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Estimated)

November 17, 2027

Study Completion (Estimated)

November 17, 2028

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 052.MTP.2021.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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