The Role of B Cells in Kidney Allograft Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Blood collection prior to and after kidney transplantation
研究概览
简要总结
The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.
详细描述
The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune responses after kidney transplantation. This study aims to address two major challenges in kidney transplantation: 1. to guide physicians when immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the process of developing antibody-mediated rejection. In this study, blood will be collected from kidney transplant patients during different timepoints, prior to and after their transplant. Knowledge gained from study findings will be used to develop therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft loss in kidney transplant patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and willingness to sign the written informed consent form (ICF). For pediatric patients, a parent or legal guardian must sign ICF
- •Either a Kidney or Liver transplant patient: 1) on the waitlist or 2) transplanted
- •Healthy volunteer samples collected to use as the control group for statistical validity
排除标准
- •Inability to make all of the required long-term post-transplant visits.
- •Females who are pregnant or nursing a child
- •Liver patients with hepatitis C virus
研究组 & 干预措施
Kidney Transplant
Patients who are about to undergo a kidney transplant and are on immunosuppressive agents.
干预措施: Immunosuppressive Agents (Drug)
结局指标
主要结局
Blood collection prior to and after kidney transplantation
时间窗: 1,3,6,12,18,24,36,48, and 60 months
Blood will be collected from kidney transplant patients prior to and after their transplant (1-, 3-, 6-, 12-, 18-, 24-, 36-, 48-, and 60- months post-transplant). We will try to better understand the role of specific B-cells after kidney transplant by using enzyme-linked immunosorbent assay (ELISA).
次要结局
- B cell count(Up to 60 months)