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NCT05224583 Clinical Trial

Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

Kidney Transplant Infection Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05224583
Other study ID # 052.MTP.2021.D
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 17, 2021
Est. completion date November 17, 2022

Study information
Verified date February 2022
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Simultaneous Liver-Kidney Transplant
Simultaneous Liver-Kidney Transplant

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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).
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