Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

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

• Status: Enrolling by invitation
• Conditions: Liver Transplant Infection; Kidney Transplant Infection; Polyomavirus Infections; BK Viremia
• Intervention / Treatment: Procedure: Simultaneous Liver-Kidney Transplant

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 (Anticipated): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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).	Procedure: Simultaneous Liver-Kidney Transplant; 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 MDMC.	number of SLK transplant recipients who were transplanted at MDMC	over a 6-year period (2015 to 2020).

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Anticipated): November 17, 2022
• Study Completion (Anticipated): November 17, 2022

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 9, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; DNA Virus Infections; Sepsis; Infections; Communicable Diseases; Viremia; Polyomavirus Infections
• 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