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临床试验/NCT04693325
NCT04693325Unknown不适用

PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
18
试验地点
2
主要终点
glomerular filtration rate (GFR)

研究概览

简要总结

The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.

详细描述

Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool.

Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Patients undergoing 1st or 2nd kidney transplant
  • Patients undergoing a kidney transplantation from DCD Maastricht III & V
  • Transplant recipients aged ≥ 18 years
  • Written informed consent

排除标准

  • Patients undergoing 3rd or subsequent kidney transplant
  • Patients undergoing a kidney transplantation from DCD Maastricht I, II & IV
  • Transplant recipients aged < 18 years
  • Patients receiving multi-organ transplants
  • ABO/HLA incompatible transplants
  • Highly sensitized patients with a panel-reactive antibody (PRA) ≥85%
  • Kidneys with CIT > 12 hrs at the point of arrival at transplant centre
  • Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder)
  • Kidneys explanted from a donor on normothermic regional perfusion

结局指标

主要结局

glomerular filtration rate (GFR)

时间窗: 6 months post transplantation

renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

次要结局

  • glomerular filtration rate (GFR)(3 months post transplantation)
  • primary non-function(6 months post transplantation)
  • delayed graft function (DGF)(6 months post transplantation)
  • patient and graft survival(6 months post transplantation)
  • adverse events(6 months post transplantation)
  • postoperative complications(6 months post transplantation)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

ipjalwayn

Prof. dr.

Leiden University Medical Center

研究点 (2)

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