A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 9
- 主要终点
- Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
研究概览
简要总结
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.
详细描述
This is a prospective, multicenter sample collection study within a kidney transplant population.
Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure).
De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.
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
- •Willing and able to provide written informed consent
- •Is 18 years of age or older at enrollment
- •Had a kidney transplant prior to enrollment
- •Is having an indication (for cause) biopsy as determined by clinician
- •retrospective leftover samples are available from the kidney donor(s).
排除标准
- •Is pregnant
- •Had a blood transfusion within the past 4 weeks
- •Had a transplant from an identical (monozygotic) twin
- •Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
- •Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
- •Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
研究组 & 干预措施
Kidney transplant recipients
Kidney transplant recipients who are 18 years of age or older
结局指标
主要结局
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
时间窗: 18 months
Collected samples will be used for research and development of a noninvasive in- vitro diagnostic test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.
次要结局
未报告次要终点