NCT00717470已完成4 期
A Multicenter, Four Arm, Randomized, Open Label Clinical Study Investigating Optimized Dosing in a Prograf®-/Advagraf®-Based Immunosuppressive Regimen in Kidney Transplant Subjects (OSAKA Study)
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
- 1,252
- 主要终点
- Efficacy failure rate
研究概览
简要总结
To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus
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 —（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 renal transplantation or re-transplantation (unless the graft was lost from rejection within 12 months)
- •Receiving a kidney transplant from a cadaveric or living (non HLA identical) 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
排除标准
- •Receiving or having previously received an organ transplant other than a kidney
- •Cold ischemia time of the donor kidney > 30 hours
- •Receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest)
- •Significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor
- •Requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- •Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation.
- •Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- •Pregnant woman or breast-feeding mother
- •Subject or donor known to be HIV positive
- •Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
- •Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully
- •Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
- •Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
研究组 & 干预措施
Advagraf (dose 2) + MMF + steroids
Active Comparator
oral
干预措施: Mycophenolate Mofetil (Drug)
Prograf + MMF + Steroids
Active Comparator
oral
干预措施: Prograf® (Drug)
Prograf + MMF + Steroids
Active Comparator
oral
干预措施: Mycophenolate Mofetil (Drug)
Prograf + MMF + Steroids
Active Comparator
oral
干预措施: methylprednisolone / prednisone (Drug)
Advagraf (dose 1) + MMF + steroids
Active Comparator
oral
干预措施: Advagraf® (Drug)
Advagraf (dose 1) + MMF + steroids
Active Comparator
oral
干预措施: Mycophenolate Mofetil (Drug)
Advagraf (dose 1) + MMF + steroids
Active Comparator
oral
干预措施: methylprednisolone / prednisone (Drug)
Advagraf (dose 2) + MMF + steroids
Active Comparator
oral
干预措施: Advagraf® (Drug)
Advagraf (dose 2) + MMF + steroids
Active Comparator
oral
干预措施: methylprednisolone / prednisone (Drug)
Advagraf + MMF + Basilixmab + steroids
Active Comparator
oral
干预措施: Advagraf® (Drug)
Advagraf + MMF + Basilixmab + steroids
Active Comparator
oral
干预措施: Mycophenolate Mofetil (Drug)
Advagraf + MMF + Basilixmab + steroids
Active Comparator
oral
干预措施: Simulect (Drug)
Advagraf + MMF + Basilixmab + steroids
Active Comparator
oral
干预措施: methylprednisolone / prednisone (Drug)
结局指标
主要结局
Efficacy failure rate
时间窗: 24 weeks
次要结局
- Renal Function, acute rejection, Biopsy confirmed acute rejection(24 weeks)
研究者
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