NCT00720265已完成3 期
A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 主要终点
- Acute rejection within 24 weeks (6 months)
研究概览
简要总结
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment
排除标准
- •Patient has previously received an organ transplant other than a kidney
- •Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
- •Patients has received an ABO incompatible donor kidney
- •Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
- •Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- •Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
- •Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
- •Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
- •Patient has a known hypersensitivity to tacrolimus
- •Patient is pregnant or lactating
研究组 & 干预措施
1
Active Comparator
干预措施: Prograf (Drug)
2
Experimental
干预措施: MR4 (Drug)
结局指标
主要结局
Acute rejection within 24 weeks (6 months)
时间窗: 6 months
次要结局
- Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)(at 6 months)
- Time to first acute rejection episode(for 6 months)
- 6 month patient and graft survival rate(at 6 months)
- Severity of acute rejection(6 months)
- Adverse events, laboratory parameters and vital signs(Throughout trial)
研究者
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