NCT00170820已完成4 期
A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen
适应症
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
- Renal function at M6 (glomerular filtration and tubular function).
研究概览
简要总结
The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second renal transplantation (1 to 10 years post-transplant)
- •Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin
- •Exclusion Criteria
- •Treatment with a CNI or azathioprine
- •Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
- •Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply
排除标准
- 未提供
结局指标
主要结局
Renal function at M6 (glomerular filtration and tubular function).
次要结局
- Mucous and cutaneous disorders
- Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH
- Renal function (other tubular function parameters)
- Incidence of biopsy-proven acute rejections and CMV infections
- Monitoring of everolimus trough levels.
- Adverse events and serious adverse events, premature study treatment discontinuations.
研究者
研究点 (1)
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