Risk Factors Associated With the Absence of CMV-specific Cellular Immune Response in the Early Post-transplant Period in Low-risk CMV-seropositive Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236
- 试验地点
- 1
研究概览
简要总结
The goal of this observational study is to identify risk factors associated with the absence of CMV-specific cellular immune response in low-risk CMV-seropositive kidney transplant recipients in the early post-transplant period. The participant population includes adult CMV-seropositive kidney transplant recipients who did not receive antithymocyte globulin (ATG) induction therapy and underwent QuantiFERON-CMV testing within the first 45 days after transplantation.
The main question it aims to answer is:
- Is it possible to predict which patients will fail to develop a CMV-specific cellular immune response before day 45 post-transplant in the absence of directly available immune assessment techniques?
Researchers will compare patients with reactive QuantiFERON-CMV results to patients with non-reactive or indeterminate results to identify factors associated with the absence of CMV-specific cellular immune response.
Participants will have retrospective clinical and laboratory data collected from medical records.
详细描述
Study Hypothesis: In the absence of available techniques to assess CMV-specific cellular immunity, it may be possible to predict which patients will fail to develop a CMV-specific cellular immune response before day 45 post-transplant.
Objective:
Primary objective:
- Derivation Cohort: To evaluate the risk factors associated with a non-reactive or indeterminate QF-CMV result before day 45 post-transplant in CMV-seropositive (R⁺) recipients who did not receive ATG prophylaxis.
- Validation Cohort: To validate these risk factors in an independent validation cohort.
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age >18 years
- •Kidney or pancreas-kidney transplant recipients with positive CMV serology
- •QF-CMV test performed on day 45 post-transplant (window period between day 30 and day 60 post-transplant)
- •CMV PCR testing performed at least every two weeks during the first three months post-transplant
排除标准
- •HIV-infected patients
- •Multivisceral transplant recipients
- •Patients scheduled to receive universal prophylaxis despite having a reactive QF-CMV result
- •Patients who received ATG induction therapy
- •Less than 6 months of post-transplant follow-up