跳至主要内容
临床试验/NCT07006532
NCT07006532招募中不适用

Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
GFR

研究概览

简要总结

Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.

详细描述

The trial is an open-labeled randomized clinical trial that evaluates the safety and efficacy of Tocilizumab as an add-on therapy to standard of care treatment of Plasmapheresis, IVIG, and Rituximab in treatment of CAMR in kidney transplant recipients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Signed written informed consent
  • eGFR> 25 cc/min
  • Chronicity index <8
  • EBV IgG positive

排除标准

  • Active or recurrent infections
  • History of malignancy, unless in remission for more than 2 years with no relapse
  • abnormal liver function tests
  • Platelet < 100,000

研究组 & 干预措施

Intervention

Other

Standard of care plus Tocilizumab

干预措施: Tocilizumab (Drug)

Standard of care

No Intervention

Plasmapheresis plus Rituximab plus IVIG

结局指标

主要结局

GFR

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

cc/min/1.73 m

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

nooshin dalili

assistant professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

Loading locations...

相似试验