A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With MMF and Steroids in Patients Undergoing Kidney Transplantation and a Pharmacokinetics Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Event rate of patients with acute rejections
研究概览
简要总结
The patients about to undergo kidney transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent with the date of the patient must be obtained.
- •Patient between 18-70 years of age receiving the primary kidney.
- •Female patients must have a negative pregnancy test prior to the enrolment.
- •Female patients of child bearing potential must agree to practice effective birth control during the study.
排除标准
- •Kidney re-transplantation patients or received an organ transplantation other than a kidney.
- •PRA>10% in the previous 6 months.
- •Patient who need antibody induction therapy.
- •Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
- •Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
- •Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
- •Patient is HIV or HBsAg positive.
- •Patient is allergic to Prograf or macrolide antibiotics.
研究组 & 干预措施
1
In combination with MMF and steroids
干预措施: FK506MR (Drug)
1
In combination with MMF and steroids
干预措施: Mycophenolate Mofetil (Drug)
1
In combination with MMF and steroids
干预措施: Methylprednisolone (Drug)
1
In combination with MMF and steroids
干预措施: Prednisolone (Drug)
2
In combination with MMF and steroids
干预措施: Prograf (Drug)
2
In combination with MMF and steroids
干预措施: Mycophenolate Mofetil (Drug)
2
In combination with MMF and steroids
干预措施: Methylprednisolone (Drug)
2
In combination with MMF and steroids
干预措施: Prednisolone (Drug)
结局指标
主要结局
Event rate of patients with acute rejections
时间窗: 12 weeks
次要结局
- Rate of patient and graft survival following transplantation(12 Weeks)
- Incidence of and time to acute rejections(12 Weeks)
- Overall frequency of acute rejections(12 Weeks)