Phase 2 Study of IVIg and Rituximab for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Kidney Transplantation
研究概览
简要总结
Some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. These patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. There are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. In this study the investigators will give two medications (IVIg and Rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. After the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. If a compatible organ offer is received, the investigators will perform the transplant using that organ. The investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75
- •End-stage renal disease on dialysis
- •Panel Reactive Antibody (PRA) > 60%
- •Have been evaluated for and are currently listed for deceased donor renal transplantation
排除标准
- •Have contraindication to transplantation
- •Have contraindication to receiving IVIG
- •Have allergy to IVIG
- •Have received IVIG for desensitization previously without effect
- •Pregnant women or those intending to become pregnant
研究组 & 干预措施
IvIg with Rituximab
干预措施: IVIg and rituximab (Drug)
结局指标
主要结局
Time to Kidney Transplantation
时间窗: 4 months
次要结局
- Decrease in Panel Reactive Antibody(4 months)
