A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).
研究概览
简要总结
This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
sotrastaurin (100mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (Dose 1) + tacrolimus + standard of care medications (Drug)
Arm 2
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (Dose 2) + tacrolimus + standard of care medications (Drug)
Arm 3
sotrastaurin (300mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (Dose 3) + tacrolimus + standard of care medications (Drug)
Arm 4
mycophenolic acid (720mg bid) + tacrolimus + standard of care medications
干预措施: mycophenolic acid + tacrolimus + standard of care medications (Drug)
结局指标
主要结局
Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).
时间窗: Month 6
次要结局
- Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine)(Months 6, 12, 24, and 36)
- Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).(Months 12, 24, and 36)
- Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).(Months 6, 12, 24, and 36)
- Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).(Months 6, 12, 24, and 36)