A Multicenter, Randomized, Comparison, Open-label, Phase IV Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Change in the GFR before the treatment (baseline) to that on Week 24
研究概览
简要总结
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.
详细描述
The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.
The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.
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
- •Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
- •Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
- •The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
- •GFR≥30 mL/min
排除标准
- •Had received an organ transplant other than a kidney
- •Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
- •Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
- •The subject received a kidney transplant from full-HLA identical donor
- •Known to have FSGS or MPGN Type II as an underlying disease
- •Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
- •Has liver cirrhosis
研究组 & 干预措施
Corticosteroid with the 50% reduced dose
oral
干预措施: Advagraf (Drug)
Corticosteroid with the 50% reduced dose
oral
干预措施: Corticosteroid (Drug)
Corticosteroid with the maintained dose
oral
干预措施: Advagraf (Drug)
Corticosteroid with the maintained dose
oral
干预措施: Corticosteroid (Drug)
结局指标
主要结局
Change in the GFR before the treatment (baseline) to that on Week 24
时间窗: Baseline and Week 24
次要结局
- Change in the GFR before the treatment (baseline) to that on Week 12(Baseline and Week 12)
- Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24(Baseline, Week 12 and Week 24)
- Incidence of acute rejection(Up to Week 24)
- Safety assessed by the incidence of adverse events, vital signs and Lab-test(Up to Week 24)
- Physical examinations including cyclosporine related cosmetic side effect(Up to Week 24)