A National Multicentre Randomized Study Comparing the Early Versus Delayed Administration of Everolimus in de Novo Kidney Transplant Recipients at Risk of Delayed Graft Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
研究概览
简要总结
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maintaining efficacy, when compared to the immediate administration of everolimus in de novo renal transplant patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipients of cadaveric kidney transplants
- •Patients at risk of DGF defined as one or more of the following:
- •Donor age > 55 years
- •Cold ischemic time (CIT) ≥ 24 hours but < 40 hours
- •Second or subsequent renal transplantation
排除标准
- •Patients who have received an investigational drug within 4 weeks of baseline period
- •Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
- •Patients with body mass index (BMI) > 32 kg/m2
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Immediate Everolimus
Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
干预措施: Everolimus (RAD001) (Drug)
Delayed Everolimus
Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
干预措施: Everolimus (RAD001) (Drug)
结局指标
主要结局
Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months
时间窗: Month 3
"In Failure", is at least one of these events occurred within the first 3 months: delayed graft function(DGF), (need for dialysis within the first 7 days,minus day one,post-transplantation); Biopsy proven acute rejection (BPAR), Graft loss, (allograft was presumed lost on the day the patient started and not removable from dialysis). Death; Loss to follow-up; Wound healing disorder(Any wound related to the kidney transplantation being opened beyond 3 weeks, or infected, or drained fluid or herniated was considered not healed).
次要结局
- Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.(at 6 Month post-transplantation)
- Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.(at 12 Month post-transplantation)
- Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period(Month 12)
- Duration of Dialysis(12 months)
- Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period(Month 12)