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临床试验/NCT05238220
NCT05238220已完成不适用

Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

Piedmont Healthcare1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2021年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Use of Viracor CMV immunity assay

研究概览

简要总结

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

详细描述

Kidney transplant patients that are cytomegalovirus (CMV) seronegative (IgG negative) at time of transplant and receive a graft from a donor that is CMV seropositive (IgG positive) are at increased risk of developing post-transplant CMV viremia and disease. These patients receive standard CMV prophylaxis with valganciclovir for 6 months post-transplant. However, a considerable proportion of these patients (25 - 42% at our center over the last 5 years) will go on to develop CMV viremia and/or disease after this valganciclovir prophylaxis is discontinued. To date, there is no strong data regarding whether certain patients would benefit from extension of valganciclovir prophylaxis beyond the standard 6-month period.

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

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

入选标准

  • Able to provide consent
  • Kidney Transplant Recipients
  • Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)

排除标准

  • 未提供

研究组 & 干预措施

continue valganciclovir prophylaxis

continue valganciclovir prophylaxis for up to 12 months total when anti-CMV immunity absent

干预措施: Valganciclovir (Drug)

结局指标

主要结局

Use of Viracor CMV immunity assay

时间窗: 6 months post-transplant through 12 months prophylaxis

continue valganciclovir prophylaxis for additional time due to absence of demonstrated anti-CMV immunity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Klein

Transplant Nephrologist

Piedmont Healthcare

研究点 (1)

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