NCT06013358招募中不适用
The Efficacy of Donor-derived Cell-free DNA as a Biomarker for Subclinical Antibody-mediated Rejection in de Novo Anti-HLA DSA-positive Recipients Who Maintain Stable Renal Function After Kidney Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- diagnostic accuracy of subclinical ABMR
研究概览
简要总结
The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation. This will be achieved through the measurement of donor-derived cell-free DNA. The utility of donor-derived cell-free DNA will be validated based on histological findings using Receiver Operating Characteristics (ROC) curve analysis.
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
- •Recipients aged 18 and above
- •Patients with de novo DSA positivity post-kidney transplantation and stable renal function: De novo HLA DSAs encompass both class I and class II, with Mean Fluorescence Intensity (MFI) greater than
- •Stable renal function is defined as serum creatinine variation of less than 15% compared to the last 6 months.
- •Patients with detected de novo HLA-DSAs but did not undergo histological examinations.
排除标准
- •Multi-organ transplant recipients
- •Recipients with positive preformed DSAs
- •ABO-incompatible transplant recipients
- •Pediatric recipients under 18 years old at the time of transplantation
- •Recipients lost to follow-up observation
- •atients already subjected to histological examinations due to positive De novo HLA-DSAs.
结局指标
主要结局
diagnostic accuracy of subclinical ABMR
时间窗: 10 years within kidney transplantation
次要结局
未报告次要终点
研究者
研究点 (1)
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