跳至主要内容
临床试验/NCT04414111
NCT04414111进行中(未招募)不适用

Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation

St. Louis University2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
2
主要终点
Delayed graft function

研究概览

简要总结

Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Adult kidney transplant candidates immediately prior to their kidney transplant surgery

排除标准

  • < 18 years old
  • Active immunosuppressive drug use
  • Hepatitis C

结局指标

主要结局

Delayed graft function

时间窗: 1 week

Delayed graft function defined as dialysis requirement within the first week after kidney transplant

Slow graft function

时间窗: 24 hours

Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant

次要结局

  • Acute rejection(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry B. Randall, MD, MBA, FACS

Professor of Surgery

St. Louis University

研究点 (2)

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