Immune Monitoring in Sensitized Patients at Risk of Rejection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Immune monitoring in sensitized patients at risk of rejection
研究概览
简要总结
The purpose of this study is to test the effect of anti-rejection medications on your immune system
详细描述
Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older able to consent
- •No history of HIV, hepatitis C and active hepatitis B infection
排除标准
- •Patients on Coumadin
- •Human Leukocyte antigen (HLA) identical donor recipient patients
结局指标
主要结局
Immune monitoring in sensitized patients at risk of rejection
时间窗: 2 years
Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation
次要结局
- Kidney Solid Organ Response Test (kSORT) with pathological findings(2 years)
