NCT00650468已完成4 期
A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients
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
- 397
- 主要终点
- Assessment of death, graft loss, or severe acute rejection
研究概览
简要总结
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
early steroid cessation
干预措施: tacrolimus (Drug)
1
Experimental
early steroid cessation
干预措施: CellCept (Drug)
1
Experimental
early steroid cessation
干预措施: steroids (methylprednisone or prednisone) (Drug)
2
Experimental
long-term maintenance steroids
干预措施: tacrolimus (Drug)
2
Experimental
long-term maintenance steroids
干预措施: CellCept (Drug)
2
Experimental
long-term maintenance steroids
干预措施: steroids (methylprednisone or prednisone) (Drug)
结局指标
主要结局
Assessment of death, graft loss, or severe acute rejection
时间窗: 6 months, 12 months, yearly up to 5 years
次要结局
- Comparison of patient and graf survival(6 months, 12 months, yearly up to 5 years)
- Incidence and severity of acute rejection(6 months, 12 months, yearly up to 5 years)
- Need for antilymphocyte treatment(6 months, 12 months, yearly up to 5 years)
- Graft function(6 month, 12 months, yearly up to 5 years)
- Framingham Coronary Heart Disease Risk Factors(6 months, 12 months, yearly up to 5 years)
研究者
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