NCT05193565进行中（未招募）4 期
Multi-center, Open-label, Randomized Controlled Phase 4 Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients Undergoing Maintenance Therapy With CNI Plus MPA.[CORAL Study]
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 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 after conversion to RaparoBell® or Myrept® in patients who in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
详细描述
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to RaparoBell® or Myrept® administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Mycophenolic acid.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who at least 1 year and less than 10 years after kidney transplantation
- •Over 20 years old
- •Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolic acid after kidney transplantation
排除标准
- •Patients who have transplanted organs other than kidney
- •At the time of Screening
- •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
- •Protein/Creatinine ratio≥1.0(mg/mg)
- •Patents who had a record of taking mTOR inhibitor before 3 months
- •In investigator's judgement
研究组 & 干预措施
RaparoBell Tablet
Experimental
RaparoBell Tablet
干预措施: Sirolimus (Drug)
Mycophenolate Mofetil Tablet/Capsule
Active Comparator
Myrept Tablet/Capsule
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
Incidence of composite efficacy failure
时间窗: Until 24 weeks
Composite efficacy failure include biopsy-confirmed acute rejection, graft loss, death, or follow-up failure
次要结局
- Survival rate of Patients(Until 24 weeks)
- Incidence of BKV, CMV infection(Until 24 weeks)
- Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy(Until 24 weeks)
- Incidence of biopsy-confirmed acute rejection(TCMR, AMR)(Until 24 weeks)
- Survival rate of transplanted organ(Until 24 weeks)
- Serum-Cr, eGFR(Until 24 weeks)
研究者
研究点 (1)
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