BK Virus Infection, CMV, Kidney Diseases, Kidney Injury, TTV Virus
Conditions
Keywords
Biomarkers testing, Kidney transplant rejection, T-ID Assay, TRAC Assay cell free DNA, Biopsy, dd-cfDNA, T-ID
Brief summary
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney transplantation, accounting for the net immune environment (TTV viral load) and allograft injury (donor-derived cell-free DNA, dd-cfDNA).
Detailed description
* To characterize time-updated viral detection patterns (e.g., transient vs sustained CMV or BK signals) identified by T-ID prior to development of CMV disease or BKVAN. * To evaluate the clinical utility of T-ID monitoring, defined by the frequency and type of clinical management actions taken following test results. * To estimate the diagnostic performance of T-ID for clinically meaningful viral infection compared with standard-of-care (PCR) testing and clinical adjudication. * To quantify lead time between T-ID detection of viral cfDNA and standard-of-care confirmation or initiation of therapy. * To assess the safety of biomarker-informed management, including both rejection following infection-directed management and infection following rejection-directed management.
Interventions
DIAGNOSTIC_TESTBlood tests, TRAC( cell free DNA) and T-ID
Blood collection
Sponsors
Transplant Genomics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must meet all the following criteria: * Written informed consent and HIPAA authorization obtained prior to any study-related data collection. * Age ≥18 years at the time of enrollment. * Recipient of a kidney transplant, including: * Primary or repeat kidney transplantation * Living-donor or deceased-donor transplantation * At 1 month post-kidney transplant at the time of enrollment. * Receiving maintenance immunosuppressive therapy per institutional standard of care. * Selected by the treating provider to undergo TRAC testing as part of usual post-transplant clinical monitoring.
Exclusion criteria
* Recipient of a combined organ transplant involving a non-renal solid organ (e.g., kidney-liver, kidney-heart) and/or islet cell transplantation. * History of prior non-renal solid organ transplantation or islet cell transplantation. * Known pregnancy at the time of enrollment. * Known active viral infection at enrollment with any of the following: * Hepatitis B surface antigen (HBsAg)-positive * Hepatitis B virus (HBV) nucleic acid testing (NAT)-positive * Human immunodeficiency virus (HIV) infection or HIV NAT-positive * \*Known active BK virus-associated nephropathy (BKVAN) or CMV disease at the time of enrollment. * Medical, psychiatric, or social condition that, in the opinion of the Investigator, would interfere with the participant's ability to provide informed consent or comply with study procedures. * Concurrent participation in another investigational biomarker study designed to evaluate clinical utility of post-transplant molecular diagnostics. * Participants with asymptomatic or low-level viral replication detected during routine clinical monitoring are eligible, provided there is no evidence of established CMV disease or BK virus-associated nephropathy at enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of the study is the time to first occurrence of either cytomegalovirus (CMV) disease or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months post-kidney transplantation. | 12 Months | * CMV disease will be defined according to standard clinical criteria, including CMV syndrome and/or tissue-invasive CMV disease, as determined by the treating clinician and documented in the medical record. * BK virus-associated nephropathy (BKVAN) will be defined as biopsy-proven BK virus nephropathy, characterized by histopathologic features consistent with BKVAN (including intranuclear viral inclusions and/or positive SV40 large T-antigen staining), in the setting of documented BK viral replication by standard-of-care testing (e.g., plasma or urine PCR). |
Contacts
CONTACTIsioma Agboli, MD
CONTACTBethany Barrick
Outcome results
None listed