Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation
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
- 否
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
Henry B. Randall, MD, MBA, FACS
Professor of Surgery
St. Louis University
