Immune Registry for BK in Kidney Transplant Recipients

Recruiting

• Conditions: BK Virus Infection; Kidney Transplant; Complications
• Interventions: Other: Collection of blood samples; Other: Data Collection; Other: Urine Sample

• Registration Number: NCT06538961
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

As with other viral infections, adaptive immunity plays an essential role in the control of BK virus infection. Previous studies have shown that humoral immunity doesn't prevent viral reactivation and cellular responses including CD4+ and CD8+ T cells play a crucial role in containing viral replication. Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased risk of developing BK virus infection in the first year post-transplant. We plan to understand the role of adaptive immunity (cellular and humoral interplay) in a cohort with at least 50% of high immunological KT recipients with predominantly retransplant candidates, highly sensitized recipients with calculated panel reactive antibodies \> 40 %, positive crossmatch or history of prior desensitization therapies.

The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins (IVIG).

Study Timeline

• Study Start: 2024-05-29
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main study	Collection of blood samples	Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.
Sub-study	Data Collection	Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia. The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.
Sub-study	Urine Sample	Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia. The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.
Sub-study	Collection of blood samples	Single organ deceased donor Kidney Transplant Recipient who are newly diagnosed with BK Viremia. The sub-study group are enrolled once they are diagnosed with BK viremia post-transplant.
Main study	Data Collection	Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.
Main study	Urine Sample	Single organ deceased donor kidney transplant recipients. Main study group subjects are enrolled at the time of transplant.

Primary Outcome Measures

Name	Time	Method
Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus	24 months	Assessing the effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre- and post-KT through clinical chart review, abnormal value or result from a clinical or laboratory evaluation, by assessing humoral and cellular responses against BK virus through BK specific T cell response, immunoglobulin G targeting BK levels, urine gene expression test to detect for BK virus and rejection.

Secondary Outcome Measures

Name	Time	Method
To identify the frequency risk of BK viremia	24 month	To identify the frequency risk of BK viremia post-transplant with careful monitoring of cellular and humoral responses against BK measured using BKV T cell immunity panel test, BKV IgG test, uromap(urine gene expression test to detect for BK virus and rejection), clinical chart review and abnormal values or results from a clinical laboratory evaluation including BKV PCR.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States