Department of Renal Medicine, Singapore General Hospital, Singapore
SingHealth Duke-NUS Transplant Centre, Singapore.
BMJ Open. 2023 Sep 19;13(9):e076122. doi: 10.1136/bmjopen-2023-076122.
Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression, but are also at risk of graft loss from rejection with underimmunosuppression. Biomarkers that predict both iRAEs and rejection while allowing individualisation of immunosuppression exposure are lacking. Although plasma viral DNA levels of torque teno virus (TTV), a widely prevalent, non-pathogenic virus, have been shown to predict both iRAE and rejection in newly transplanted KTRs within the first year after transplant, its role for prevalent KTRs on stable immunosuppression is less clear.This study aims to determine the prognostic value of TTV levels for severe infections (defined as infections requiring hospitalisation) in prevalent KTRs on stable immunosuppression for at least 3 months and compare it against that of other commonly available biomarkers. The study also aims to explore the relationship between TTV levels and factors affecting the 'net state of immunosuppression' as well as other clinical outcomes.
This is a single-centre, prospective, observational cohort study of 172 KTRs on stable immunosuppression for more than 3 months. TTV levels will be measured using the TTV R-GENE kit upon recruitment when study subjects are admitted and when kidney allograft biopsies are performed. Subjects will be monitored for iRAEs and rejection for at least 12 months. The relationship between TTV load and clinical outcomes such as severe infections will be analysed and compared against that from other common biomarkers and previously published predictive scores.
The study was approved by the SingHealth Centralised Institutional Review Board (2023/2170). The results will be presented at conferences and submitted for publication in peer-reviewed journals.
NCT05836636.
肾移植受者（KTR）遭受免疫抑制相关不良事件（iRAE），如慢性免疫抑制引起的感染和恶性肿瘤，但也有因免疫抑制不足导致移植物排斥而丧失移植物的风险。缺乏既能预测 iRAE 又能预测排斥反应，同时又能个体化免疫抑制暴露的生物标志物。虽然已证明新移植的 KTR 在移植后 1 年内，其血浆中广泛存在的非致病性病毒——扭结藤病毒（TTV）的病毒 DNA 水平可预测 iRAE 和排斥反应，但对于稳定免疫抑制下的常见 KTR ，其作用尚不清楚。本研究旨在确定 TTV 水平对稳定免疫抑制至少 3 个月的常见 KTR 严重感染（定义为需要住院治疗的感染）的预后价值，并与其他常用生物标志物进行比较。该研究还旨在探讨 TTV 水平与影响“免疫抑制净状态”的因素以及其他临床结果之间的关系。
这是一项单中心、前瞻性、观察性队列研究，纳入了 172 名稳定免疫抑制至少 3 个月的 KTR。在招募时，当研究对象入院和进行肾移植活检时，将使用 TTV R-GENE 试剂盒测量 TTV 水平。将对受试者进行至少 12 个月的 iRAE 和排斥反应监测。将分析 TTV 负荷与严重感染等临床结果的关系，并与其他常见生物标志物和先前发表的预测评分进行比较。
该研究得到了 SingHealth 集中机构审查委员会的批准（2023/2170）。研究结果将在会议上展示，并提交给同行评议期刊发表。
NCT05836636。
