A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
研究概览
简要总结
Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).
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
Everolimus + Cyclosporine
Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
干预措施: Steroids (Drug)
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
干预措施: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) (Drug)
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
干预措施: Steroids (Drug)
Everolimus + Cyclosporine
Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
干预措施: Everolimus + Cyclosporine (Drug)
结局指标
主要结局
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
时间窗: From Baseline to Month 12
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
时间窗: From Baseline to Month 12
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
次要结局
- Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.(From Baseline to Month 3, 6, and 12)
- Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.(From Baseline to Month 1, 3, 6, 9, and 12)
- Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).(From Baseline to Month 3, 6, and 12)
- Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12(From Baseline to Month 3, 6, and 12)
- Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.(Month 6 and 12)
- Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.(Month 12)
- Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12(From Baseline to Month 3, 6, and 12)
- Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12(From Baseline to Month 3, 6, and 12)
- Assessing Cardiovascular Risk Factors Based on Fasting Glucose.(From Baseline to Month 1, 3, 6, 9, and 12)
- Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.(From Baseline to Month 1, 3, 6, 9, and 12)