NCT05727709招募中不适用
Dynamic Changes of Torquetenovirus Load in Chinese Renal Transplant Recipients During Immunosuppressive Therapy: A Double-blind Multicenter Prospective Observational Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- Renal allograft biopsy and serum creatinine
研究概览
简要总结
The goal of this observational study is to learn about dynamic changes of Torquetenovirus (TTV) load in Chinese renal transplant recipients. The main questions it aims to answer are:
- Is there correlation between TTV load and rejection?
- Is there correlation between TTV load and infection?
- Can changes in the TTV load of kidney transplant recipients predict rejection or infection?
Participants will:
- receive 13 follow-up visits within 1 year after kidney transplantation
- provide 2 ml of whole blood for TTV load testing and other related testing at each follow-up
- provide 10 ml of whole blood for dd-cfDNA testing at four follow-ups (1, 3, 6 and 12 months after transplantation)
- provide 1 ml of serum for donor-specific antibody testing at three follow-ups (1, 6 and 12 months 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
- •Receiving ABO compatible renal allotransplantation from the initiation of the study to December 31, 2023
- •Receiving tacrolimus /mycophenolate mofetil(or mycophenolic acid)/prednisone as maintenance immunosuppression after renal transplantation
- •Receiving universal prophylaxis for CMV infection and PJP infection
排除标准
- •Receiving combined liver-kidney, pancreas-kidney or heart-kidney transplantation
- •Recipients with active hepatitis B or hepatitis C infection
- •Recipients with anticipated irregular follow-up
结局指标
主要结局
Renal allograft biopsy and serum creatinine
时间窗: From day0 to day365 after kidney transplantation
Any biopsy-proven acute rejection (Banff criterea) and clinical diagnosed acute rejection
次要结局
- donor-specific antibodies (DSA)(From day0 to day365 after kidney transplantation)
- donor derived cell-free DNA(From day0 to day365 after kidney transplantation)
- Infection event(From day0 to day365 after kidney transplantation)
研究者
Gang Chen
Professor, Deputy director of Institute of OrganTransplantation
Tongji Hospital
研究点 (5)
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