Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum creatinine
研究概览
简要总结
The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.
详细描述
When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living donor kidney transplantation recipients
- •patients who were performed kidney biopsies because of laboratory and clinically suspected rejection
- •Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative
- •Single luminex panel reactive antibody (PRA) I & II mean fluorescent intensity (MFI) < 3000
排除标准
- •patients who received other major organ transplantation
- •combined with urinary tract infection or obstruction
- •combined with acute antibody mediated rejection
- •poor compliance
研究组 & 干预措施
Bortezomib
Bortezomib (subcutaneous) 1.3mg/m2 on day 1, 4 and 7
with
Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage
干预措施: Bortezomib (Drug)
Bortezomib
Bortezomib (subcutaneous) 1.3mg/m2 on day 1, 4 and 7
with
Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage
干预措施: Steroid (Drug)
Steroid
Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage
干预措施: Steroid (Drug)
结局指标
主要结局
Serum creatinine
时间窗: Day 14
Investigators measure patients' serum creatinine at day 14.
次要结局
- Incidence of steroid failure(Day 7)
- Serum creatinine(Month 1)
- Infection(Until 1 year after intervention)
- Recurrence of Rejection(Until 1 year after intervention)
研究者
Su-Kil Park
Professor
Asan Medical Center