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临床试验/NCT03794817
NCT03794817已完成不适用

Immune Monitoring in Sensitized Patients at Risk of Rejection

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015年8月20日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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