NCT05477082进行中（未招募）不适用
Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Biopsy-proven acute rejection
研究概览
简要总结
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant recipients
- •Participants undergoing a for-cause kidney biopsy to rule out graft rejection
- •Ages 21 years and less
排除标准
- •Participants who have opted out of research
- •Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read.
- •Participants, 18 years and older, who are illiterate and cannot read.
- •Participants, less than 18 years of age, whose parents or legal guardians do not speak English.
- •Participants, 18 years and older, who do not speak English
- •Participants who are pregnant as confirmed by medical records
结局指标
主要结局
Biopsy-proven acute rejection
时间窗: 7 days from baseline
Yes or No assessment
Clinical resolution of rejection
时间窗: 8 weeks from baseline
Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine
次要结局
未报告次要终点
研究者
研究点 (1)
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