A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus-Associated Nephropathy Following Kidney Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 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).
次要结局
未报告次要终点