NCT05224583

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2021Nov 2028

Study Start

First participant enrolled

November 17, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2028

Last Updated

March 20, 2026

Status Verified

January 1, 2026

Enrollment Period

6 years

First QC Date

February 3, 2022

Last Update Submit

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).

Procedure: Simultaneous Liver-Kidney Transplant

Interventions

Simultaneous Liver-Kidney Transplant

Simultaneous Liver-Kidney Transplant patients population at MDMC

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Polyomavirus Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Lori Kautzman, MD

    Methodist Health System

    PRINCIPAL INVESTIGATOR

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

Locations