Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

NCT ID: NCT05224583

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-17

Study Completion Date

2022-11-17

Brief Summary

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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%.

Detailed Description

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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.

Conditions

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Polyomavirus Infections BK Viremia Liver Transplant Infection Kidney Transplant Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type PROCEDURE

Simultaneous Liver-Kidney Transplant

Interventions

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Simultaneous Liver-Kidney Transplant

Simultaneous Liver-Kidney Transplant

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori Kautzman, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38605438 (View on PubMed)

Other Identifiers

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052.MTP.2021.D

Identifier Type: -

Identifier Source: org_study_id

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