Immune Registry for BK in Kidney Transplant Recipients

ConditionsBK Virus Infection Kidney Transplant; Complications

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Prisoners will not be included in the study

Multi-organ transplants and pregnant women

Trial population

The study will include adults 18 and older who have undergone single organ deceased donor Kidney Transplant.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Blood samples: Main Study group
Other intervention
the collection of blood samples at specified time points.
Data Collection
Other intervention
Donor and Recipient's clinical information including clinical history, demographic characteristics labs, and imaging.
Urine Sample- Main Study group
Other intervention
-Post-transplant monthly urine sample collection for 6 months in 10-18% of subjects
Urine sample- Sub-study group
Other intervention
\- Post-transplant monthly urine sample collection for 6 months in all subjects
Blood sample: Sub-study group
Other intervention
Monthly blood sample collection for 6 months

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Main study3 interventions

Group B: Sub-study3 interventions

Trial outcomes

Primary outcomes

Assessing the effect of kidney transplant immunosuppression therapy on the immune response against BK virus

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.

Time frame

24 months

Secondary outcomes

To identify the frequency risk of BK viremia

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.

Time frame

24 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Eurofins

Collaborator

Source ClinicalTrials.gov

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