Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

• Sponsor: Methodist Health System (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05224583
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Polyomavirus Infections; BK Viremia; Liver Transplant Infection; Kidney Transplant Infection	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant Recipients: A Retrospective Single-Center Review
• Actual Study Start Date: Nov 17, 2021
• Anticipated Primary Completion Date: Nov 17, 2022
• Anticipated Study Completion Date: Nov 17, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. To characterize the prevalence of BKV in the SLK patient population at MDMC. [over a 6-year period (2015 to 2020).]

   number of SLK transplant recipients who were transplanted at MDMC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

• Methodist Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Methodist Health System
• ClinicalTrials.gov Identifier: NCT05224583
• Other Study ID Numbers: 052.MTP.2021.D
• First Posted: Feb 4, 2022
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Viremia; Polyomavirus Infections

Study Results

No Results Posted as of Mar 9, 2022