NCT06044493已完成4 期
A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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 MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients
详细描述
This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.
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
- •Over 19 years old
- •Patients who at least 1 year after kidney transplant
- •serum creatinine ≤2.3 mg/dL
- •Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation
排除标准
- •Patients who had received treatment Acute rejection within 4 weeks
- •Patients who had discontinued corticosteroid within 4 weeks
- •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
- •In investigator's judgement
研究组 & 干预措施
Myreptic-N Tablet
Experimental
Mycophenolate sodium
干预措施: Myreptic-N Tablet (Drug)
Myrept Tablet/Capsule
Active Comparator
Mycophenolate mofetil
干预措施: Mycophenolate mofetil Tablet/Capsule (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
- Incidence of Virus infection(Until 24 weeks)
- Incidence of biopsy-confirmed acute rejection(Until 24 weeks)
- Incidence of Death(Until 24 weeks)
- Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)](Changes in scores from the baseline at week 24)
- Intra patient variability of mycophenolic acid(Until 24 weeks)
- Incidence of Graft loss(Until 24 weeks)
- Intra patient variability of calcineurin inhibitor(Until 24 weeks)
研究者
研究点 (1)
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