跳至主要内容
临床试验/NCT03714113
NCT03714113Unknown不适用

Clinical Significance of Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年10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
100
试验地点
2
主要终点
Presence of anti-HLA donor-specific antibodies.

研究概览

简要总结

The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.

详细描述

Monitoring of immune response is one of the most important goals in the management of the patients after kidney transplantation. Researchers and clinicians are trying to extend the survival of the renal graft. Currently, it is believed that the main cause of late transplant loss is antibody-mediated rejection (ABMR). Anti-HLA donor-specific antibodies (DSA) are a proven risk factor for the development of humoral rejection and transplant loss. Antibodies in sensitized recipients occur before transplantation (preformed) or may develop de novo (in 13% -30% of patients).

DSA damage the graft in various mechanisms (complement activation, direct influence on endothelial cells, antibody-dependent cytotoxicity) leading to different clinical-morphological phenotypes. The pathogenicity of DSA is determined by number of their additional characteristics, such as: class, specificity, strength, C1q complement binding, IgG subclass . Monitoring the presence of DSA in the kidney recipient serum with the determination of their characteristics may improve the stratification of the risk of immunological loss of the renal allograft.

There is no effective treatment for ABMR, hence DSA monitoring allows for early intervention such as biopsy or modification of immunosuppressive therapy at an early stage of rejection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Deceased-donor kidney transplant recipient
  • Older than 18 years
  • Written consent by the patient

排除标准

  • Younger than 18 years
  • Lack of written consent by the patient

结局指标

主要结局

Presence of anti-HLA donor-specific antibodies.

时间窗: 24 months

Binary variable (positive/negative).

次要结局

  • Presence of IgG2 subclass of anti-HLA DSA.(24 months)
  • Mean fluorescence intensity (MFI) of anti-HLA DSA.(24 months)
  • Presence of C1q complement binding anti-HLA DSA.(24 months)
  • Presence of IgG1 subclass of anti-HLA DSA.(24 months)
  • Presence of IgG3 subclass of anti-HLA DSA.(24 months)
  • Presence of IgG4 subclass of anti-HLA DSA.(24 months)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验