跳至主要内容
临床试验/NCT03708094
NCT03708094已完成不适用

A Study for Predicting the Prognosis of Renal Transplantation by the Clear Pathogenic Gene of End-stage Renal Disease in Children

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
1
主要终点
Renal graft survival rate

研究概览

简要总结

Kidney transplantation is the worldwide recognized best renal replacement treatment for children with end-stage renal disease. Successful kidney transplantation can not only alleviate uremia symptoms, improve survival and quality of life, but also achieve optimal growth and cognitive development in children. Clarifying the cause of end-stage renal disease before transplantation is of vital importance to the comprehensive assessment and follow-up of the extra renal organs, reducing the risk of recurrence of the primary disease, the choice of the timing and the mode of transplantation, the scheme of immunosuppressive agents, as well as providing accurate genetic counseling for families. Timely molecular diagnosis and correct data analysis play a positive role in promoting the etiological diagnosis of uremic children before renal transplantation. We hypothesized that identifying the molecular diagnosis can improve prognosis of kidney transplantation. 300 cases of end-stage renal disease children were included and whole exome sequencing are performed to identify the molecular diagnosis. The cohort was divided into 2 groups according to whether the molecular diagnosis was clear. Clinical information before and after renal transplantation of each group are collected, and the decision tree analysis model and logistic regression model are used to study the effect of clear molecular diagnosis on the 3 year survival rate of renal 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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Donors and recipients who accepted kidney transplantation at centers included in this study

排除标准

  • Older than 18 years old.
  • There are severe systemic diseases and/or local and/or spiritual system diseases.
  • There are systemic acute or chronic infections, infectious diseases.
  • The donated organ dysfunction, or other causes that are damage to donors and recipients.

结局指标

主要结局

Renal graft survival rate

时间窗: 3 years after renal transplantation

The number of survival renal transplant graft in the 3 year observation period accounted for the percentage of the total cases studied.

次要结局

  • Recurrence rate of primary disease(3 years after renal transplantation)
  • Incidence of acute rejection(3 years after renal transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hong Xu,MD.PhD

Professor

Children's Hospital of Fudan University

研究点 (1)

Loading locations...

相似试验