Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06538961

Conditions

BK Virus Infection

Kidney Transplant; Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood samples: Main Study group

Data Collection

Urine Sample- Main Study group

Urine sample- Sub-study group

Blood sample: Sub-study group

Study Details

Brief summary:

Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.

Conditions

BK Virus Infection

Kidney Transplant; Complications

Study ID

NCT06538961

Start date

May 29, 2024

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (>18 years old) male and female, deceased donor KT recipients
  • Will include single organ transplants.
  • Each participant must also have recently been diagnosed with BK viremia.
  • In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab).

Exclusion Criteria:

  • Prisoners will not be included in the study
  • Multi-organ transplants and pregnant women

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Main study

Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.

Sub-study

Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia or those with difficult-to-treat BKV > 3 logs (BKV log does not decrease by more than 1 log copy/ml drop on second per protocol lab). The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.

Interventions

Blood samples: Main Study group

the collection of blood samples at specified time points.

Data Collection

Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.

Urine Sample- Main Study group

-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects

Urine sample- Sub-study group

\- Post-transplant monthly urine sample collection for 6 months in all subjects

Blood sample: Sub-study group

Monthly blood sample collection for 6 months

Primary outcome measure

  • Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Ambreen Azhar

804-828-4104ambreen.azhar@vcuhealth.org

Gelila Abebe

(804) 628-4969gelila.abebe@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Ambreen Azhar

804-828-4104ambreen.azhar@vcuhealth.org

Gelila Abebe

804-628-4969gelila.abebe@vcuhealth.org

Principal Investigator:

Gaurav Gupta

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Immune Registry
  • BK in Kidney Transplant Recipients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-20.