NCT04368962Unknown不适用
DSA Risk Factors in Chinese Kidney Transplant Patients Using MPA-based Immunosuppression Protocol: A Multi-center Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- DSA 12 month
研究概览
简要总结
Kidney transplantation is the best therapy method for patients with uremia. The main factors affecting the long-term survival of the graft were chronic antibody-mediated rejection and the death of the patients. Newborn donor special antibody (DSA) is a major risk factor for chronic antibody-mediated rejection (AMR) and poor transplantation outcomes. Detection of mycophenolate mofetil (MMF) trough concentration can help estimate its exposure. Deficient exposure of MMF can lead to AMR after transplantation surgery. The aim of this study is to estimate the risk factors of one-year DSA after transplantation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •years 18-65
- •single organ transplantation
- •first time to accept kidney transplantation
- •Triple immunosuppression protocol based on MMF, tacrolimus and glucocorticoid
- •PRA negative before transplantation
- •not pregnant for female
排除标准
- •Not accept MMF
- •multi-organ transplantation
- •pregnancy or lactation period female
- •mental illness
- •past tumor, peptic ulcer, severe cardiopulmonary disease, active liver disease history
- •Cannot regular follow up
结局指标
主要结局
DSA 12 month
时间窗: 2021.5-2023.5
newborn DSA in recipient serum in the first 12 month after transplantation
次要结局
- AR(2020.5-2023.5)
- DSA risk factors(2020.5-2023.5)
- MPA-AUC(2020.5-2023.5)
- allograft function(2021.5-2023.5)
- DSA 6 month(2020.12-2022.12)
研究者
研究点 (1)
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