Effects of Age on Immune Risk Profile in CMV Seropositive Kidney Transplant Recipients After Release From CMV Prophylaxis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
研究概览
简要总结
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are cytomegalovirus (CMV) seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint. In addition, clinical data will be collected at the time points indicated, particularly renal function and the presence/absence of acute rejection.
详细描述
Using novel CYTOF technology to measure a wide array of innate and adaptive cell proportions and cytokine levels, we plan a pilot study in old (>/=60 years) and young (20-40 years) renal transplant recipients who are CMV seropositive (regardless of donor serology). Viral load measurements will be performed at baseline prior to transplant (within 1 week),and then at 3, 7 and 10 months after transplant. It is expected that the patient will receive anti-CMV prophylaxis until 6 months post-transplant, so the latter two time points will reflect responses after "release" from antiviral suppression. Each patient will serve as their own control, with comparisons made between measurements at baseline and then at each timepoint.
Blood from 10 patients in each age group will be studied, to collect virologic and immune response data:
- CYTOF (broad array of measurements)
- Tetramer assays (requires recipient HLA type of A1, A2, B7)
- CMV viral load PCR
- Response to pneumococcal antigens and inactivated influenza virus
In addition, clinical data will be collected at the time points indicated,particularly renal function and the presence/absence of acute rejection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults young age 20-40 years and old >/= 60 years
- •Anticipate renal transplant within 2 weeks
- •CMV sero-positive renal transplant recipients
- •HLA type of A1, A2, B7 of recipient
排除标准
- •Pediatric recipients
- •Multi-organ transplant recipients
- •Highly sensitized (antigen level) recipients
- •Prior organ transplant recipients
- •Patients who do not wish to participate in study, or who cannot consent to research
- •Patients with active CMV infection
- •Seronegative
- •HLA Type of organ recipient not corresponding to A1,A2, B7
结局指标
主要结局
CMV viral loads in older seropositive kidney transplant recipients before transplant, during treatment and after therapy
时间窗: 1 year
CMV viral loads in older (age \>/= 60) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
CMV viral loads in younger seropositive kidney transplant recipients before transplant, during treatment and after therapy
时间窗: 1 year
CMV viral loads in younger (age 20-40) seropositive kidney transplant recipients before renal transplant, during treatment with anti-viral therapy, and after release from therapy
次要结局
未报告次要终点