NCT00223678已完成4 期
Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors 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
- 20
- 试验地点
- 1
- 主要终点
- Graft Survival
研究概览
简要总结
A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol
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 the recipient of a cadaveric or living donor renal transplant.
- •Patient was > 12 years of age at the time of transplant.
- •Patient is at least 3 months post-transplant.
- •Patient has been on a calcineurin inhibitor based immunosuppression since the transplant.
- •Patient has one of the following risk factors for chronic renal allograft failure:
- •I. Serum creatinine > 2.0 mg/dL 3 months or later post-transplant in males patients.
- •II. Serum creatinine > 1.7 mg/dL 3 months or later post-transplant in female patients.
- •III. Serum > 30% increased over post discharge nadir.
- •Patients had a renal biopsy that shows chronic allograft nephropathy.
- •Patient or legal guardian had signed and dated an Institutional Review Board (IRB) approved informed consent document and is willing and able to follow study procedures.
- •If female and of child bearing potential, patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF), Rapamycin and other immunosuppressants.
排除标准
- •Patient is the recipient of a solid organ transplant other than the kidney.
- •Patient is dialysis dependent.
- •Patient has recurrence of primary renal disease, or de novo renal disease.
- •Patient has an estimated creatinine clearance <25ml/min calculated using the Cockcroft/Gault formula.
- •Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within three months of randomization.
- •Baseline biopsy shows acute rejection Banff Grade > Class 2 (IIB).
- •Patient required anti-lymphocyte therapy to treat rejection found on baseline biopsy.
- •Patient has received an investigational immunosuppressant within three months.
- •Patient is pregnant or lactating.
- •Patient is a known carrier of any of the HIV viruses.
- •Patient has known hypersensitivity to Rapamycin, or any of the excipients of the drug.
研究组 & 干预措施
1
Active Comparator
pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin
干预措施: Rapamycin (Drug)
结局指标
主要结局
Graft Survival
时间窗: 3 years
次要结局
未报告次要终点
研究者
Anthony Langone
Anthony Langone M.D.
Vanderbilt University Medical Center
研究点 (1)
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