Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- graft survival
研究概览
简要总结
Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.
详细描述
20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms
: ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection
排除标准
- •Mixed AMR and T cell rejection
- •do not sign the consent
研究组 & 干预措施
Plasmapheresis plus Bortezomib
Drug 5 Sessions Plasmapheresis and 100 mg/kg Intra venous immunoglobulin at the end of each session and one dose 375ml/m2 rituximab at the end of last session plus bortezomib Injections 1.3mg/m2 intravenously on days 1, 4, 8, and 11
干预措施: Bortezomib (Drug)
结局指标
主要结局
graft survival
时间窗: at month 6 following diagnosis
Glomerular Filtration Rate
次要结局
- Renal functional tests(at month 6 following diagnosis)
- Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology(at month 6 following diagnosis)
- DSAs-MFI(at month 6 following diagnosis)
研究者
nooshin dalili
Principal Investigator
Shahid Beheshti University of Medical Sciences