Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of CMV disease at 12 months after transplantation
研究概览
简要总结
Hypothesis: Valganciclovir prophylaxis can be discontinued before 3 months in CMV-seropositive renal transplant recipients receiving induction thymoglobulin when developing CMV-specific cellular immunity after transplantation.
Objective Meet the efficacy and safety of valganciclovir prophylaxis suspend in CMV-seropositive kidney transplant recipients with CD8 + cellular immunity CMV-specific transplant, receiving Thymoglobulin induction and maintain cellular immunity-specific CD8 + CMV after transplantation.
Design: noninferiority clinical trial (study A) in CMV-seropositive kidney transplant recipients with CMV-specific cellular immunity pretransplant (Quantiferon reactive CMV) received induction with thymoglobulin
Patients meeting inclusion criteria will be randomized to:
- Control Arm: valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS (Transplantation 2013:96:333-360).
- Experimental arm: prophylaxis with valganciclovir and determination of CMV-specific cellular immunity day +15, +30, +45 and +60. Prophylaxis was discontinued when the patient developed CMV-specific cellular immunity. Patients who did not develop CMV specific immunity continue prophylaxis until day +90.
Analysis: The incidence of CMV disease according to the strategy used was calculated using Kaplan-Meier curves that were compared using the log-rank test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Renal transplant CMV-Seropositive
- •CD8+ Tcell CMV especific pretransplant (CMV-reactive quantiferon pretrasplant)
- •> 18 years (adult)
- •Receiving Thymoglobulin induction therapy
- •Receiving Valganciclovir prophylaxis
- •Written informed consent for trial entry
排除标准
- •Multivisceral transplants including kidney-pancreas.
- •HIV-infected Patients
- •Patients who can not comply with the monitoring protocol.
研究组 & 干预措施
New profilaxis
Prophylaxis is discontinued when the patient developed CMV-specific cellular immunity.
干预措施: New profilaxis (Drug)
Profilaxis recommended by TTS
Valganciclovir prophylaxis until day +90 as recommended by the International Consensus document of the TTS.
干预措施: Profilaxis recommended (Drug)
结局指标
主要结局
Incidence of CMV disease at 12 months after transplantation
时间窗: 12 months
Incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation criteria for use in clinical trials
次要结局
- Incidence of CMV replication(12 months)
- Percentage of patients who recover CMV-specific CD8+ T-cell immunity in the posttransplantation period after receiving thymoglobulin induction therapy and valganciclovir prophylaxis(12 months)