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临床试验/NCT03798860
NCT03798860已完成不适用

Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 340 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
状态
已完成
入组人数
340
试验地点
1
主要终点
Donor-specific Antibodies Clearance

研究概览

简要总结

Single-arm, prospective observational study

详细描述

This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all patients after lung transplantation with detection of donor-specific antibodies

排除标准

  • 未提供

结局指标

主要结局

Donor-specific Antibodies Clearance

时间窗: 6, 12, 18, 24 months

The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.

次要结局

  • Graft survival(1, 3, 5 years)
  • Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)(1, 3, 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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