Validating Cell-based Assays for ABMR After Renal Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Antibody-mediated rejection
研究概览
简要总结
Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation. These cell based assays measure CD154-expressing alloantigen-specific B-cells and their subsets in peripheral blood of adult renal transplant recipients. Thirty recipients will be enrolled at two transplant centers, 10 each with ABMR, T-cell mediated rejection (TCMR), and no rejection. Each subject will be sample twice, before and after rejection. Donor-specific anti-HLA antibodies will also be measured with single antigen beads.
详细描述
This cross-sectional open label study will evaluate whether alloantigen-specific B-cells and their subsets which express CD154 are associated with antibody-mediated rejection after first time renal transplantation in adult recipients.
Control groups include adult renal transplant recipients with T-cell-mediated rejection, and without rejection of any type.
Alloantigen-specific B-cells will be measured after stimulation of recipient peripheral blood leukocytes with those from corresponding donor and HLA-non-identical reference cells.
Thirty total subjects will be enrolled after IRB-approved informed consent, 15 at each of two sites. These subjects will include ten each with biopsy-proven ABMR and TCMR and ten with no rejection.
Each subject will be sampled twice, before and after treatment rejection, at intervals no less than 30 days, and not to exceed 90 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IRB-approved informed consent.
- •Adults (>18 yr to 70 years)
- •Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection
排除标准
- •Lack of informed consent
- •Concomitant BK virus infection
- •Vulnerable populations including children <18 yr, pregnant women, and prisoners
结局指标
主要结局
Antibody-mediated rejection
时间窗: up to 90 days per subject
Biopsy-proven antibody-mediated rejection after primary renal transplantation
次要结局
- T-cell mediated rejection (TCMR)(up to 90 days per subject)