Multi-center, Open-label, Prospective, Randomized, Parallel Group, Long-term Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a CNI-free Regimen and a CNI-low Dose Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 1
- 主要终点
- GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen
研究概览
简要总结
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.
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 70 Years（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
CNI free regimen
CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids
干预措施: Everolimus (Drug)
CNI standard regimen
Myfortic, Sandimmun Optoral and corticosteroids
干预措施: Myfortic (Drug)
CNI standard regimen
Myfortic, Sandimmun Optoral and corticosteroids
干预措施: Sandimmun Optoral (Drug)
CNI standard regimen
Myfortic, Sandimmun Optoral and corticosteroids
干预措施: Simulect® (Drug)
CNI free regimen
CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids
干预措施: Myfortic (Drug)
CNI free regimen
CNI free regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids
干预措施: Sandimmun Optoral (Drug)
CNI low regimen
CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids
干预措施: Everolimus (Drug)
CNI low regimen
CNI low regimen: comprising the following steps for switching treatment:
Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids
干预措施: Sandimmun Optoral (Drug)
结局指标
主要结局
GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen
时间窗: From randomization at BL2 (Month 3) to Month 12 post-transplant
Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted
次要结局
- GFR Via Nankivell Formula at Month 12 - All Regimens(From randomization at BL2 (Month 3) to Month 12 post-transplant)
- GFR at Month 12 Utilizing Cockcroft-Gault Formula(From randomization at BL2 (Month 3) to Month 12 post-transplant)
- GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method(From randomization at BL2 (Month 3) to Month 12 post-transplant)
- Efficacy Event Data From Baseline 2 (Month 3) to Month 6(From Baseline 2 (Month 3) to Month 6)
- Mean Change in Serum Creatinine From Month 3 to Month 12(From randomization at BL2 (Month 3) to Month 12 post-transplant)
- Efficacy Event Data Baseline 2 (Month 3) to Month 12(From Baseline 2 (Month 3) to Month 12)
- Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)(From Baseline 2 (Month 3) to Month 12)
- GFR Calculated Via Nankivell Formula at Month 60(From randomization at BL2 (Month 3) to Month 60)
- GFR at Month 60 Utilizing Cockcroft-Gault Formula(From randomization at BL2 (Month 3) to Month 60 post-transplant)
- GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method(From randomization at BL2 (Month 3) to Month 60 post-transplant)
- Mean Change in Serum Creatinine From Month 3 to Month 60(From randomization at BL2 (Month 3) to Month 60 post-transplant)
- Efficacy Event Data After Month 12 to Month 60(Events starting after Month 12)