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临床试验/NCT05756036
NCT05756036已完成不适用

Torque Teno Virus: A Biomarker of Immunosuppression in Kidney Transplantation, an Observational Single Centre Study

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2022年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
268
试验地点
1
主要终点
The correlation between TTV viral load and Biopsy proven graft rejection

研究概览

简要总结

To seek an association between Torque Teno Virus DNA titres resulting from under or over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of circulating NK, B and T lymphocyte subtypes.

详细描述

Balancing the adverse effects of over-immunosuppression such as infection and malignancy, to the risk of rejection, remains the central challenge for day-to-day clinical practice in transplantation. A quantitative measure of immunocompetence remains elusive, and in the absence of such markers, immunosuppression drug concentrations and clinical events, such as organ rejection, infection, malignancy etc. are used as surrogate markers of immunocompetence to guide therapy. As demonstrated in several studies, the Torque teno virus is widespread amongst the general population. In theory, if one suppresses the immune system, these viruses should multiply, resulting in a higher DNA level which can be detected by a simple blood test. Hence, the DNA level could be used as an indicator for the level of immunosuppression, along with the available blood tests to measure the level of toxicity of the said drugs.

In this research to be done at the Royal London Hospital, the investigators aim to elucidate that the Torque teno virus is widely prevalent in an ethnically diverse East London kidney transplant recipient population by conducting the viral PCR on blood samples already collected during their routine clinic visits. The population will include all kidney transplant recipients in a two-year period. The investigators will measure the correlation between the TTV DNA level and drug concentrations of the immunosuppressive medications which will elucidate how the DNA levels are affected by different drug concentrations. The investigators will then measure the correlation between the TTV DNA levels, and the common adverse outcomes experienced by the transplant recipients, namely, patient death, loss of transplant organs, transplant rejection, rates of infection, and cancers in transplant patients by collecting data from patient records. These tests will help understand whether the Torque teno virus DNA levels can be used as a marker of immunosuppression in the general population in the UK.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All consenting renal transplant recipients in the study period will be included in the study

排除标准

  • no exclusion criteria.

研究组 & 干预措施

Renal transplant recipients

All incident renal transplant recipients after the commencement of the study

干预措施: None Observational study (Other)

结局指标

主要结局

The correlation between TTV viral load and Biopsy proven graft rejection

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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