Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
研究概览
简要总结
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 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
Everolimus + CNI reduction
Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice.
干预措施: Everolimus (Drug)
Everolimus + CNI reduction
Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice.
干预措施: Calcineurin inhibitors (CNI) (Drug)
Everolimus + CNI reduction
Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice.
干预措施: Steroids (Drug)
Control
CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
干预措施: Mycophenolic acid (MPA)/azathioprine (AZA) (Drug)
Control
CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
干预措施: Calcineurin inhibitors (CNI) (Drug)
Control
CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
干预措施: Steroids (Drug)
结局指标
主要结局
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
时间窗: Baseline to Month 12
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
次要结局
- Change in Serum Creatinine From Baseline to End of Study (Month 24)(Baseline to end of study (Month 24))
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup(Baseline to end of study (Month 24))
- Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)(Month 12 to end of study (Month 24))
- Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup(Baseline to end of study (Month 24))
- Mean Days of Hospitalization From Baseline to End of Study (Month 24)(Baseline to end of study (Month 24))
- Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)(Month 12 to end of study (Month 24))
- Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup(Baseline to end of study (Month 24))
- Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup(Baseline to end of study (Month 24))
- Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)(Baseline to end of study (Month 24))
- Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)(Month 12 to end of study (Month 24))
- Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)(Month 12 to end of study (Month 24))