NCT01842269已完成4 期
Open Label, Randomized, Multi-center, Phase 4 Trial to Evaluate the Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) Versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination With Tacrolimus for 26 Weeks in Kidney Transplant Patients
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
- 156
- 试验地点
- 11
- 主要终点
- Rate of efficacy failure
研究概览
简要总结
Efficacy and Safety of My-Rept® Tablet(Mycophenolate Mofetil 500mg/Tab.) versus My-Rept® Capsule(Mycophenolate Mofetil 250mg/Cap.) in Combination with Tacrolimus in Kidney Transplant Patients
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
- •Age 20 years or older.
- •Patient who receive primary or secondary kidney transplantation from living or brain-dead donor .
- •Patient who receive age 20 years or older donor.
- •Willing and able to provide written informed consent.
排除标准
- •Cold Ischemia Time > 30 hours.
- •Patient who receive HLA-identical donor.
- •Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
- •Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
- •Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
- •Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.
- •Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma)
- •Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.
- •Patient with Severe gastrointestinal disease in screening period by investigator's decision.
- •Patient with systemic severe infection requiring treatment (able to transplantation after completely disappear or is controlled infection)
- •Liver cirrhosis, clinically significant portal hypertension or other moderate to severe liver disease.
- •Defined by the following laboratory parameters before screening period
- •One of liver function test(AST, ALT, ALP, Total Bilirubin)results increased more than 3 times upper limit of normal range
- •WBC <2,500/mm3, Platelet <75,000/mm3
- •Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives.
- •Administration of other Investigational drugs and/or immunosuppressants within 28days before screening period (except allowed immunosuppressants in protocol)
- •Women in pregnant or breast-feeding or don't using adequate contraception.
- •Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
- •In investigator's judgment
研究组 & 干预措施
My-Rept® Tablet
Experimental
My-Rept® Tablet, Mycophenolate Mofetil 500mg, orally
干预措施: Mycophenolate Mofetil 500mg (Drug)
My-Rept® Capsule
Active Comparator
My-Rept® Capsule, Mycophenolate Mofetil 250mg, orally
干预措施: Mycophenolate Mofetil 250mg (Drug)
结局指标
主要结局
Rate of efficacy failure
时间窗: up to 26 weeks
efficacy failure=acute rejection by kidney biopsy,graft loss, death
次要结局
- Rate of acute rejection by kidney biopsy(up to 26 weeks)
- Survival with no graft loss(up to 26 weeks)
- eGFR(using by MDRD method)(up to 26 weeks)
- Number of Participants with Adverse Events(up to 26 weeks)
研究者
研究点 (11)
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