Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
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
- 否
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
Christina Klein
Transplant Nephrologist
Piedmont Healthcare
