EUCTR2006-001945-32-BE进行中（未招募）1 期
Introduction of everolimus is associated with a reduction in the dosage of calcineurine-inhibitors in patients with a pulmonary graft who suffer from a notable chronic renal insuffisance.
B Erasme0 个研究点目标入组 15 人开始时间: 2006年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- •1)introduction of a severe chronical renal insufficience(CRI) (DFG < 50 ml/min/1.73 m2) which was progressive during the last 2 years or CRI which rapidely progresses (a loss of > 50 % DFG in 3 months) en isotopic glomerular filtration < 45 ml/min
- •even when the following changes:
- •a)switch from cyclosporine A (Neoral) to tacrolimus (Prograft)
- •b)Optimalisation of prograft dosage (minimum 1 profil PK that shows an AUC0-12h between 100 – 200 ?g/h/l or at least 3 dosages C3 that show a level between 10 and 20 ng/ml)
- •c)Optimalisation of immunosuppression by introduction of azathioprine (Imuran) or mycophénolate mofétil (Cellcept)
- •d)HTA in balance (Holter TA récent, < 130/90 mmHg in the absence of protéinurie, < 120/80 mmHg in the présence of protéinurie)
- •e)correctly treated diabetes (HbA1c < 7 % récente)
- •2)Absence of recent severe rejection (6 mois) and/or progressive BOS
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Recent severe rejection (the last 6 months)
- •2)recent severe infections (the last 6 months)
- •3)active hepatic pathology
- •4)Coronaropathie in the cardiac transplant in case of a heart-lung transplant
- •5)Uncontrolled Reflux
- •6)hématological anomalies : leucopenie (< 4000/mm3), anémie (hémoglobine < 7 gr %), thrombocytopénie (platelets < 150.000 / mm3)
- •7)fasting Cholesterol > 240 mg%
- •8)glomerular Filtration < 25 ml / ‘ / 1.73 m2
研究者
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