NCT00637143已完成4 期
Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
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
- 107
- 主要终点
- Graft Survival
研究概览
简要总结
The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.
详细描述
The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
- •Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
- •Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
- •Serum creatinine: Male: >=2.0mg/dL (176.8 umol/L); Female: >= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
- •Serum creatinine > 30% increased over post-discharge nadir
- •Patient has had a renal biopsy > 3 months after transplant and within 6 months prior to enrollment
- •Patient or legal guardian has signed and dated an IRB approved informed consent document
- •Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)
排除标准
- •Patient is dialysis dependent and has recurrence of primary or de novo renal disease
- •Patient has an estimated creatinine clearance <25mL/min
- •Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
- •Baseline biopsy shows acute rejection Grade >=IIB using Banff 95 criteria or >= Grade IIA using Banff 97 criteria
- •Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
- •Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
- •Patient is a known carrier of any of the HIV viruses
研究组 & 干预措施
1
Experimental
Oral
干预措施: Tacrolimus (Drug)
2
Active Comparator
Oral
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Graft Survival
时间窗: 5 years
次要结局
- Patient Survival(5 years)
研究者
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终止
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