A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 830
- 主要终点
- Nankivell Glomerular Filtration Rate (GFR)
研究概览
简要总结
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 13 years.
- •Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
- •Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization
排除标准
- •Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
- •Patients in whom kidney-pancreas or other multiple organ transplants have been performed
研究组 & 干预措施
A
Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
干预措施: Sirolimus (Drug)
A
Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
干预措施: tacrolimus (Drug)
A
Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
干预措施: Cyclosporine A (Drug)
B
Continued calcineurin inhibitor therapy
干预措施: Sirolimus (Drug)
B
Continued calcineurin inhibitor therapy
干预措施: tacrolimus (Drug)
B
Continued calcineurin inhibitor therapy
干预措施: Cyclosporine A (Drug)
结局指标
主要结局
Nankivell Glomerular Filtration Rate (GFR)
时间窗: 52 weeks
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
次要结局
- First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.(52 and 104 weeks)