Desensitization With Bortezomib Before a Living Kidney Donation
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
研究概览
简要总结
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.
详细描述
The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti HLA Antibody (DSA) between 1000 and 3000 MFI with a multicentre pilot study of 10 patients. The effect of bortezomib will be observed up to 6 month after bortezomib treatment prior to transplantation and 12 month after transplantation if performed. The living kidney donation will be performed only if the DSA level drops below 1000 MFI which means an efficacy of the desensitization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 70 years old
- •awaiting a living kidney donation
- •but with a least one DSA titer between 1000 MFI and 3000 MFI
排除标准
- •positive cell dependent cytotoxicity CM,
- •DSA level above 3000 MFI
- •and every condition that is a contre indication for bortezomib treatment
研究组 & 干预措施
Bortezomib
Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
干预措施: Bortezomib (Drug)
结局指标
主要结局
Proportion of patients with Donor specific antibody (DSA) level below 1000MFI authorizing the living kidney donation
时间窗: up 6 months after bortezomib treatment and before transplantation
Bortezomib treatment should allow a decrease in DSA level below a threshold level authorizing the living kidney donation with minimal risk
次要结局
- Frequency of anomalies at the standard blood tests(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Proportion of transplanted patients(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Frequency of side effects(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Incidence of biopsy proven acute rejection and chronic rejection(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Frequency of clinical symptoms and anomalies(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Absolute and relative differences of the DSA titer ans antiHLA non DSA titer bortezomib treatment(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Frequency of anomalies at the total lymphocyte count and phenotyping(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)
- Frequency of proteinuria and anomalies at the glomerular filtration rate(12 month after the living kidney donation if performed or 6 month after the last bortezomib injection if the living kidney donation could not be performed)