EUCTR2007-000771-42-SE进行中(未招募)不适用
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy - CENTRA
ovartis Pharma Services0 个研究点目标入组 250 人开始时间: 2007年8月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female above 18 year
- •first or second renal transplant receipients
- •willing and capable of giving written informed consent
- •at randomisation:
- •maintained on a triple immunosuppresive regime
- •completed period 1 without experiencing biopsy proven acute rejection
- •negative pregnancy test and on medically approved birth control metod
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •recipients of multi organ transplants
- •receiving renal transplant from HLA-identical sibling
- •past or present malignancy
- •receipients of ABO incompatible transplants
- •at randomisation:
- •hemoglobin count <80g/l and/or platelet count <50x109/l and/or white blood cell count < 2.5 x 109/l)
- •spot urinary protein/creatinine ratio >150 mg/mmol
- •requiring dialysis and/or having a cGFR <20ml/min
研究者
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