NCT01404325已完成3 期
A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy Regarding Renal Function of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, Purinantagonists and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months
研究概览
简要总结
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Quadruple low level IS regimen
Experimental
quadruple immunosuppressive (IS) regimen consisting of everolimus, CNI, MPA and steroids
干预措施: Everolimus (Drug)
Centre specific triple IS regimen
Experimental
centre specific CNI-based triple drug immunosuppression (IS)
干预措施: standard therapy (Drug)
结局指标
主要结局
Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months
时间窗: Month 12
Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)\^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1
次要结局
- Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12.(Baseline, Month 6, Month 12)
- Incidence of Renal Replacement Therapy at Month 6 and Month 12(Month 6, Month 12)
- Time to Renal Replacement Therapy at Month 6 and Month 12(Month 6, Month 12)
- Incidence of Acute Rejection Episodes at Month 6 and Month 12(Month 6, Month 12)
- Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12(Month 6, Month 12)
- Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12(Month 6, Month 12)
- Incidence of Death at Month 6 and Month 12(Month 6, Month 12)
- Quality of Life (QoL, SF36) at Month 6 and Month 12(Month 6, Month 12)
- Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12(Month 6, Month 12)
- Incidence of Treated Arterial Hypertension up to Month 12(up to Month 12)
- Incidence of Diabetes Mellitus up to Month 12(up to Month 12)
- Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Triglyceride Levels at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Trough Levels of Everolimus at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
- Incidence of Bacterial, Viral, and Fungal Infections at Month 12(Month 12)
- Total Cholesterol Levels at Month 1, 3, 6, 9, 12(Month 1, 3, 6, 9, 12)
研究者
研究点 (1)
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