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临床试验/NCT06505200
NCT06505200进行中(未招募)不适用

An Integrative Clinicopathological Decision Support System for Kidney Transplant Rejection

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 1,891 人开始时间: 2004年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,891
试验地点
2
主要终点
Kidney transplant failure

研究概览

简要总结

This observational cohort study aims to compile routinely collected clinical, histological and outcome data of kidney transplant recipients, to evaluate risk factors for post-transplant injury, phenotypes of injury, and impact on outcome of such injury, in order to provide clinicians more accurate, less biased and faster tools for diagnosis, clinical management and treatment decisions with regard to kidney transplant rejection.

详细描述

The following data/features are collected prospectively and structured in the electronic medical records:

Demographics:

  • Date of transplantation
  • Date of graft failure
  • Last date of follow-up
  • Time after transplantation of survival (number of days);
  • kidney survival;
  • recipient death;
  • recipient gender;
  • recipient age at time of transplantation;
  • recipient weight at time of transplantation;
  • recipient BMI at time of transplantation;
  • recipient race;
  • recipient diabetes prior to transplantation;
  • the Belgian Index for Multiple Deprivation (BIMD);
  • combined vs single transplant (we included only single transplants);
  • repeat transplant vs. first transplant;
  • diagnosis of the original kidney disease (prior to transplantation);
  • donor type (living vs. deceased);
  • donor gender;
  • donor age in years;
  • donor diabetes yes vs no;
  • HLA genotype of donors and recipients, number of HLA A mismatches between donor and recipient (0-2); number of HLA B mismatches between donor and recipient (0-2); number of HLA DR mismatches between donor and recipient (0-2); number of total HLA mismatches between donor and recipient (0-6); high-resolution genotyping of donors and recipients HLA genes (11 loci);
  • cold ischemia time
  • warm ischemia time
  • operation time

Graft functional data:

  • Serum creatinine values from day of transplantation onwards;
  • Proteinuria values from day of transplantation onwards

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • * All adult kidney transplant recipients transplanted at the University Hospitals Leuven between 01/03/2004 and 01/06/2022, without restrictions with regard to age, sex, underlying kidney disease etc.

排除标准

  • * Patients with combined transplantations (e.g. heart + kidney, liver + kidney, lung + kidney)

结局指标

主要结局

Kidney transplant failure

时间窗: 2004 - 2022

Graft failure, recipient death

次要结局

  • Kidney transplant rejection phenotypes(2004 - 2022)
  • Kidney transplant function(2004 - 2022)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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