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RECRUITING
NCT06538961

Immune Registry for BK in Kidney Transplant Recipients

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

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.

Official title: Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2024-05-29

Completion Date

2026-05

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

OTHER

Blood samples: Main Study group

the collection of blood samples at specified time points.

OTHER

Data Collection

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

OTHER

Urine Sample- Main Study group

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

OTHER

Urine sample- Sub-study group

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

OTHER

Blood sample: Sub-study group

Monthly blood sample collection for 6 months

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States