The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- effect of simvastatin on panel reactive antibody
研究概览
简要总结
Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative kidney for transplantation and are at the risk of post transplantation rejection more than other transplanted patients. We evaluated the effect of simvastatin on PRA and post transplant outcome of these sensitized patients. We also performed a descriptive study.
详细描述
The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates is associated with hyperacute or delayed humoral immune responses against the graft after transplantation .
In addition, these sensitized patients wait for a long time to find a cross-match negative kidney for renal transplantation . As a result, some modalities have been used for desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination with immunosuppressive drugs .
However, recently, the use of statins such as simvastatin, pravastatin and etc. has been proposed to be safer and more effective for 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ESRD on hemodialysis or peritoneal dialysis
- •On the waiting list for renal transplant
- •PRA more than 25%
排除标准
- •Pregnant women
- •Patients who need ongoing blood products
- •Patients taking other therapies to decrease PRA
- •Patients listed for multi-organ transplant other than kidney
- •Patients with liver failure
研究组 & 干预措施
A
patients who will take simvastatin 20 mg daily
干预措施: simvastatin (Drug)
结局指标
主要结局
effect of simvastatin on panel reactive antibody
时间窗: 12 months
次要结局
未报告次要终点