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临床试验/NCT02826811
NCT02826811Unknown不适用

Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
170
试验地点
1
主要终点
Quantification of anti-BKV

研究概览

简要总结

BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation.

In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes a transplant rejection risk estimated between 4 and 14% according to studies.

Despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing BKVN.

研究设计

研究类型
Observational
观察模型
Cohort

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

  • Patient over 18 years
  • Grafted kidney patient between 1 July 2012 and 31 July 2014 at Strasbourg University Hospital with regular monitoring

排除标准

  • Patient under 18 years

结局指标

主要结局

Quantification of anti-BKV

时间窗: up to 12 months post-transplantation

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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