Polyomavirus InfectionsNCT05224583
Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant
An observational study of Polyomavirus Infections and BK Viremia, run by Methodist Health System at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Polyomavirus Infections, BK Viremia, Liver Transplant Infection
- What is being tested?
- Simultaneous Liver-Kidney Transplant
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 17 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020).
Who may be able to join
- Age 18 years or older
- SLK recipients transplanted at MDMC between 2015-2020
Who cannot join
- Below 18 years of age
- Patients who did not undergo SLK transplant at MDMC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant Recipients: A Retrospective Single-Center Review
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%.
Read the 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.
- Conditions
- Polyomavirus Infections, BK Viremia, Liver Transplant Infection, Kidney Transplant Infection
- Being tested
- Simultaneous Liver-Kidney Transplant
- Medical subject headings
- Polyomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Liver-Kidney TransplantProcedure or surgery
Simultaneous Liver-Kidney Transplant
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Simultaneous Liver-Kidney Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over a 6-year period (2015 to 2020).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start17 Nov 2021
- Primary completion17 Nov 2027 (estimated)
- Study completion17 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Kautzman, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224583
- Sponsor's protocol ID
- 052.MTP.2021.D
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2022
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38605438
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant Recipients: A Retrospective Single-Center Review
- ClinicalTrials.gov ID
- NCT05224583
- Acronym / sponsor ID
- 052.MTP.2021.D
- Conditions
- Polyomavirus Infections, BK Viremia, Liver Transplant Infection, Kidney Transplant Infection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 Nov 2027 (estimated)
- Study completion
- 17 Nov 2028 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Liver-Kidney Transplant patients population at MDMC | – | Procedure: Simultaneous Liver-Kidney TransplantConsecutive SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- SLK transplant recipients who were transplanted at MDMC over a 6-year period (2015 to 2020).
Key inclusion criteria (2 listed)
- Age 18 years or older
- SLK recipients transplanted at MDMC between 2015-2020
Key exclusion criteria (2 listed)
- Below 18 years of age
- Patients who did not undergo SLK transplant at MDMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous Liver-Kidney TransplantSimultaneous Liver-Kidney Transplant | Procedure or surgery | Simultaneous Liver-Kidney Transplant patients population at MDMC |
Primary outcome
To characterize the prevalence of BKV in the SLK patient population at (Methodist Dallas Medical Center)MDMC.
Time frame: over a 6-year period (2015 to 2020).
number of SLK transplant recipients who were transplanted at (Methodist Dallas Medical Center)MDMC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 38605438Kotton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Kautzman, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyomavirus Infections and BK Viremia, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the prevalence of BKV in the SLK patient population at (Methodist Dallas Medical Center)MDMC. (time frame: over a 6-year period (2015 to 2020).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.