NCT00619398已完成3 期
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients and a Pharmacokinetics Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 主要终点
- Event rate of patients with acute rejections
研究概览
简要总结
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.
详细描述
A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.
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
- 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 is the recipient of a liver transplant from 6 to 24 months prior to enrollment
- •Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
- •At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is <= 2 times the upper value of normal range)
- •Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator
排除标准
- •Patient has received an organ transplant other than a kidney
- •Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
- •Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
- •Patient with liver recurrent cancer, or metastasis, or other cancer
- •Patient has any unstable medical condition that could interfere with the study objectives
- •Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
- •Patient is allergic macrolide antibiotics or tacrolimus
- •Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
- •Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)
研究组 & 干预措施
2
Experimental
干预措施: FK506MR capsule (Drug)
1
Active Comparator
干预措施: Prograf (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
- Incidence of adverse events including laboratory assessments(12 Weeks)
- Incidence of and time to acute rejections(12 Weeks)
- Overall frequency of acute rejections(12 Weeks)
- Rate of patients and graft survival following transplantation(12 Weeks)
研究者
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