NCT02032095已完成2 期
The Desensitization Therapy With GB-0998 for Anti-donor Antibody-positive Recipients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Negative rate of FCXM-T after the fourth administration of GB-0998
研究概览
简要总结
It is intended to examine the safety and efficacy of desensitization therapy by GB-0998 (intravenous immunoglobulin) for the anti-donor antibody positive recipient in need of pre-transplant desensitization. Patients with positive FCXM-T after performing twice double filtration plasmapheresis (DFPP) therapy will receive GB-0998 1g/kg/day for four days.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage 4 or 5 on the CKD classification.
- •Of the patients that wants a living-donor kidney transplant of ABO blood type compatible, patients with positive FCXM-T and negative CDC-T to the donor.
- •Patients with positive FCXM-T after performing twice DFPP therapy
排除标准
- •Patients who had taking to continue immunosuppressive drugs or steroids within 4 weeks before obtaining informed consent.
- •Patients who had IVIG therapy, or plasmapheresis therapy within 12 weeks before to informed consent.
- •Patients who had Rituximab within 6 month before to informed consent.
- •Patients who have undergone splenectomy.
- •Patients with severe hepatic disorder or severe heart disorder.
- •Patients with receiving treatment of malignancy.
- •Patients with high risk of thromboembolism.
- •Patients with history of shock or hypersensitivity to GB-
- •Patients with hereditary fructose intolerance or IgA deficiency.
- •Patients with pregnant or probably pregnant.
研究组 & 干预措施
GB-0998
Experimental
干预措施: GB-0998 (Drug)
结局指标
主要结局
Negative rate of FCXM-T after the fourth administration of GB-0998
时间窗: at 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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