Soluble B-Cell Activating Factor and a Proliferation-inducing Ligand for Transplant Risk Assessment and Prediction of Antibody-Mediated Rejection in Kidney Transplantation: a Prospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Incidence of Antibody-mediated Rejection
研究概览
简要总结
Antibody-mediated rejection (AMR) is a significant risk factor for graft loss in kidney transplantation. Soluble B cell-activating factor (sBAFF) and a proliferation-inducing ligand (APRIL) plays a critical role in the activation and differentiation of B cells, making it a potential predictive biomarker for AMR. In this prospective multicenter cohort study, the effectiveness of sBAFF/APRIL in predicting AMR after kidney transplantation is evaluated. Recipient sBAFF/APRIL levels are monitored before transplantation, and at seven days, two weeks, one month, three months, and every three months after transplantation continuously . The primary outcome is the occurrence of AMR, while the status of donor-specific antibodies (DSA), T cell-mediated rejection (TCMR), and other clinical parameters are secondary outcomes. The predictive capacity of sBAFF/APRIL for both the primary and secondary outcomes will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living donor or deceased donor kidney recipients.
- •Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months.
排除标准
- •Preoperative donor specific antibody positive .
- •Combined or multi-organ transplantation.
- •Poor compliance.
- •Unable to continue the follow-up.
- •Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).
结局指标
主要结局
Incidence of Antibody-mediated Rejection
时间窗: 24 months
Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria
次要结局
- Incidence of T cell-mediated rejection(24 months)
- Renal graft survival(24 months)
- Incidence of de novo donor-specific antibody(24 months)
- Incidence of infection(24 months)
- Estimated glomerular filtration rate (eGFR)(24 months)
- Qualitative or Quantitative meassurement of urine protein(24 months)
- Death-censored renal graft survival(24 months)
- Patient survival(24 months)
研究者
Changxi Wang
Director of Department of Kidney Transplantation, Organ Transplant Center
First Affiliated Hospital, Sun Yat-Sen University