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临床试验/NCT03423901
NCT03423901已完成不适用

Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2018年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Gene expression related to antibody mediated rejection

研究概览

简要总结

It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.

详细描述

The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Patient receiving a KT and followed at least one year in Toulouse Hospital
  • Patient who have signed informed consent
  • > 18 years old

排除标准

  • Patient under protective measures
  • Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers.
  • Immunosuppressive treatments withdrawal - Patient in chronic dialysis
  • Ongoing pregnancy or pregnancy in the past year
  • Past of splenectomy

结局指标

主要结局

Gene expression related to antibody mediated rejection

时间窗: 1 year posttransplantation

To determine expression of genes related to antibody mediated rejection (inflammation, and endothelial cell activation) by transcriptomic analyse (whole genome micro-array) on kidney biopsies

次要结局

  • description of T subsets cells(1 to 5 years posttransplantation)
  • description of B subsets cells(1 to 5 years posttransplantation)
  • Evolution of systematic annual kidney biopsies(1 to 5 years posttransplantation)
  • Evolution of creatinine clearance(1 to 5 years posttransplantation)
  • description of lymphocytes rates(1 to 5 years posttransplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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