Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The rates of kidney transplantation
研究概览
简要总结
The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.
详细描述
HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are on the waiting list more than 4 years
- •PRA I or II > 50%
排除标准
- •Recent recipients of any live attenuated vaccine(s) within 4 weeks
- •Subjects who have received IVIG or B cell depleting agents previously
- •Subjects with positive result for viral hepatitis(B,C) or HIV infection
- •Subjects with active infection
- •Lactating or pregnant females
- •Subjects who have history of malignancy in recent 5years
- •Subjects who have experience of treatment for the psychiatric problem in recent 6months
- •Subjects who have hematologic abnormality (Hb < 7g/dL, Platelet < 100,000/mm3, AST/ALT > 80IU)
研究组 & 干预措施
Group 2
This group will receive IVIG and B cell depleting agents
干预措施: High dose IVIG and B cell depleting agents (Drug)
结局指标
主要结局
The rates of kidney transplantation
时间窗: from one to five years
次要结局
- Reduction in anti-HLA alloantibodies(1year)
- Renal allograft survival(from one to five year)
- The number of serious complication(from one to five year)