Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant
1 other identifier
observational
50
1 country
1
Brief 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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2021
CompletedFirst Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 17, 2028
March 20, 2026
January 1, 2026
6 years
February 3, 2022
March 18, 2026
Conditions
Outcome Measures
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
over a 6-year period (2015 to 2020).
Study Arms (1)
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).
Interventions
Simultaneous Liver-Kidney Transplant
Eligibility Criteria
SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020).
You may qualify if:
- Age 18 years or older
- SLK recipients transplanted at MDMC between 2015-2020
You may not qualify if:
- Below 18 years of age
- Patients who did not undergo SLK transplant at MDMC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Related Publications (1)
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.
PMID: 38605438DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori Kautzman, MD
Methodist Health System
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 4, 2022
Study Start
November 17, 2021
Primary Completion (Estimated)
November 17, 2027
Study Completion (Estimated)
November 17, 2028
Last Updated
March 20, 2026
Record last verified: 2026-01