NCT02161237已完成4 期
A Multi-center, Randomized, Open-label, Pilot and Exploratory Study Investigating Safety and Efficacy in OPTIMIZEd Dosing of Advagraf® Kidney Transplantation in Asia.
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
- 73
- 主要终点
- estimated GFR
研究概览
简要总结
Primary purpose of this study is to compare renal function between subjects receiving optimized dose Advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose Advagraf®. Pilot results of safety and efficacy in optimized dose Advagraf® over 52 weeks after kidney transplantation will also be obtained.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation
- •Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
- •Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. And, male subject of childbearing potential should agree to maintain effective birth control during the study
排除标准
- •Receiving or having previously received an organ transplant other than a kidney
- •Cold ischemia time of the donor kidney > 24 hours
- •Receiving a graft from a non-heart-beating donor other than of Maastricht category 3
- •Significant liver disease
- •Receiving a graft from a hepatitis C or B positive donor
- •Requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for Lupus disease, FSGN etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy
- •Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer
- •Subject or donor known to be HIV positive
- •Known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or MMF or any of the product excipient
- •Subject has malignant tumor
- •Currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study
- •Subject with a high immunological risk
研究组 & 干预措施
standard dose group
Experimental
Oral
干预措施: Advagraf® (Drug)
optimized dose group
Experimental
Oral
干预措施: Advagraf® (Drug)
结局指标
主要结局
estimated GFR
时间窗: at Week-52 after transplantation
次要结局
- creatinine clearance(at Week-52 after transplantation)
- serum creatinine level(at Week-52 after transplantation)
- Number of graft survival(at Week-52 after transplantation)
- Subject survival(at Week-52 after transplantation)
- number of biopsy-proven acute rejection(at Week-52 after transplantation)
- Composite of graft loss, subject death and biopsy proven acute rejection(at Week-52 after transplantation)
- Time to the first acute rejection(up to Week-52 after transplantation)
- Time to the first steroid-resistant acute rejection(up to Week-52 after transplantation)
- Severity of biopsy proven acute rejection(up to Week-52 after transplantation)
- Safety assessed by the incidence of adverse events, vital signs and lab tests(for 52 weeks after transplantation)
研究者
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