The Influence of Genetic and Clinical Factors on Clinical Outcomes of Kidney Transplant Patients With Tacrolimus Based Immunosuppression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Acute rejection
研究概览
简要总结
The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.
详细描述
Tacrolimus (TAC) is the most important immunosuppressants for maintenance therapy after kidney transplantation. Many genetic and clinical factors had been found to have effect on TAC pharmacokinetics (PK). Whether these factors affect clinical outcomes is still controversial.
In this retrospective study, investigators will review records of kidney transplant patients with TAC based immunosuppression recruited from a previous study (IRB approval number: 201512005RINC) to understand the influence of clinical and genetic factors on their 3-years clinical outcomes, including biopsy-proven acute rejection, patient survival, graft survival and safety issues of kidney transplant patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplantation
- •20-65 years old
- •Receiving tacrolimus-based immunosuppressants
- •Were recruited in a previous trial
排除标准
- •Human immunodeficiency virus-positive status
- •Retransplantation or multiorgan transplantation
结局指标
主要结局
Acute rejection
时间窗: Within the first 1 year post-transplantation
The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis
Graft survival
时间窗: From post-transplantation to Dec 31, 2017
The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis
次要结局
- Kidney function measured by estimated glomerular filtration rate (eGFR)(From post-transplantation to Dec 31, 2017)
- Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia(From post-transplantation to Dec 31, 2017)
- Patient survival(From post-transplantation to Dec 31, 2017)