Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- DSA(Donor-specific Anti-HLA Antibody)
研究概览
简要总结
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
详细描述
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 19 years old(male or female)
- •Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
- •Agreement with written informed consent
排除标准
- •Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
- •Patients with high sensitization who need desensitization therapy
- •Multi organ recipients or previous transplant with any organs
- •Diagnosed with cancer within five years
- •Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
- •Patients who have positive HIV, HBsAg or Anti-HCV test result
- •At screening
- •Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
- •WBC<2,500/mm3, PLT <50,000/mm3, ANC<1,500/mm3
- •Pregnant or lactating women
- •In investigator's judgment
研究组 & 干预措施
Mycophenolate mofetil
One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
干预措施: Methylprednisolone/prednisolone (Drug)
Mycophenolate mofetil
One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
干预措施: Basiliximab (Drug)
Mycophenolate mofetil
One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
干预措施: Mycophenolate mofetil 500mg Tab. or 250mg Cap. (Drug)
Mycophenolate mofetil
One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
DSA(Donor-specific Anti-HLA Antibody)
时间窗: 36 months
Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation
次要结局
- Incidence of composite efficacy failure(12, 24, 36months)