Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared With Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO Incompatible De Novo Living Kidney Transplant Recipients. [ART Study]
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Incidence of composite efficacy failure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
详细描述
This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.
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
- •[Time of Screening]
- •Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
- •More than the age of 19 years old
- •Agreement with written informed consent
- •[Time of Randomization]
- •Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
- •Patients who take CNI plus MMF after kidney transplantation
排除标准
- •[Time of Screening]
- •Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
- •PRA > 50% before desenitization or positive results of DSA
- •Receive a kidney from a related donor who showed HLA identical
- •Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
- •Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
- •Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
- •Patient has conversation impairment because of mental illness within 6months
- •Participated in other trial within 4 weeks
- •In investigator's judgement
- •[Time of Randomization]
- •Patients with acute rejection who have been clinically treated after kidney transplantation
- •At the time of Randomization
- •Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
- •WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/mm^3
- •Patients who had plasmapheresis within 1 week
- •Patents who had a record of taking mTOR inhibitor before
- •In investigator's judgement
研究组 & 干预措施
RaparoBell® Tablet
ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.
干预措施: Sirolimus Tab. (Drug)
Mycophenolate Mofetil Tablet/Capsule
ABO-i De novo Living Kidney transplant recipients will be randomized after Kidney transplant.
干预措施: Mycophenolate Mofetil Cap./Tab. (Drug)
结局指标
主要结局
Incidence of composite efficacy failure
时间窗: Until 48 weeks after taking medicine
Composite efficacy failure include biopsy-confired acute rejection, graft loss, death, or follow-up failure
次要结局
- Incidence of composite efficacy failure(Until 24 weeks after taking medicine)
- The pathological results and time of occurrence and method of treatment, result of the treatment of acute rejection confirmed by biopsy(Until 24weeks and 48weeks after taking medicine)
- Incidence of CMV, BKV infection(Until 24weeks and 48weeks after taking medicine)
- Incidence of biopsy-confirmed acute rejection(Until 24weeks and 48weeks after taking medicine)
- Survival rate(Until 24weeks and 48weeks after taking medicine)
- Function of Kidney(Until 24weeks and 48weeks after taking medicine)