An 18 Month Extension to the Multicenter, Randomized, Open-label Trial (NCT00170885) to Evaluate the Safety, Tolerability, and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Renal Function Assessed by Creatinine Clearance
研究概览
简要总结
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with functioning graft who had completed the 6-month treatment period of core study
- •Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
- •Patients who signed the informed consent of the present study extension
排除标准
- •Women who were pregnant, lactating or who wished to became pregnant.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Upper everolimus blood target + very low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
干预措施: Everolimus 0.25 and 0.75 mg tablets (Drug)
Upper everolimus blood target + very low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
干预措施: Cyclosporine very low dose (150-300 ng/mL) microemulsion (Drug)
Standard everolimus blood target + low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
干预措施: Everolimus 0.25 and 0.75 mg tablets (Drug)
Standard everolimus blood target + low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
干预措施: Cyclosporine low dose (350-500 ng/mL) microemulsion (Drug)
结局指标
主要结局
Renal Function Assessed by Creatinine Clearance
时间窗: Month 12, Month 18, and Month 24
Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.
Number of Participants With Biopsy-proven Acute Rejection
时间窗: Baseline to end of study (Month 24)
A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.
次要结局
- Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft(Baseline to end of study (Month 24))
- Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths(Baseline to end of study (Month 24))