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临床试验/NCT02893475
NCT02893475已完成不适用

Impact de la durée de Dialyse Avant Greffe rénale Avec Donneur Vivant Sur la qualité de Vie et la réinsertion Professionnelle Des Receveurs

Central Hospital, Nancy, France0 个研究点目标入组 534 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
534
主要终点
Quality of life

研究概览

简要总结

Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.

The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).

详细描述

Living donor (LD) kidney transplantation is currently the best treatment for end-stage renal disease (ESRD) in terms of life expectancy and quality of life. This method allows preemptive transplantation, before beginning dialysis.

The main objective of this study will be to investigate quality of life and societal participation in a population of LD kidney transplant recipients comparing preemptive LD transplantation versus non-preemptive transplantation (performed after a period of dialysis).

It is hypothesized that in addition to prolonged graft survival, preemptive LD kidney transplantation is associated with less deterioration of quality of life and better societal participation.

We therefore propose a cross-sectional population-based study to include all patients who underwent LD kidney transplantation from 2004 through 2009 in the seven most active kidney transplantation centers in France. Cross-sectional surveys have been conducted since 2004 by the biomedicine agency in collaboration with the InVS in order to evaluate quality of life among ESRD patients. The most recent survey, QUAVIREIN, is in process but has included only a small number of patients selected at random. We want to broaden the study population beyond the QUAVIREIN sample in order to include the entire population of LD kidney transplant recipients.

The study population will thus include all patients who received a LD kidney transplant from 2004 through 2009 who give their informed consent to participate in the study and have a functional transplant on March 31, 2012. The seven transplantation centers have agreed to participate in the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • age >= 18 years
  • LD kidney transplantation from 2004 through 2009
  • First LD kidney transplantation in the seven most active kidney transplantation centers in France: Paris Necker, Nancy, Paris Saint Louis, Foch, Nantes, Toulouse and Montpellier
  • Patient with a functioning kidney at the time of the study
  • Patient able to read and understand French

排除标准

  • Patient with multiple transplantation including liver transplantation
  • Patient unable to read and understand French
  • Patient died or lost to follow-up

结局指标

主要结局

Quality of life

时间窗: through study completion, an average of 1 year

SF-36 and Retransqol questionnaires

次要结局

  • Societal participation(through study completion, an average of 1 year)
  • Professional reintegration(through study completion, an average of 1 year)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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