Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab
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
- 否
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
Standard of care plus Tocilizumab
干预措施: Tocilizumab (Drug)
Standard of care
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
nooshin dalili
assistant professor
Shahid Beheshti University of Medical Sciences
