A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
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 liver 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
MMF(1000mg bid) + tacrolimus + standard of care medications
干预措施: MMF(1000mg bid) + tacrolimus + standard of care medications (Drug)
Arm 2
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (200mg bid) + tacrolimus + standard of care medications (Drug)
Arm 3
sotrastaurin (200mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (200mg bid) + tacrolimus + standard of care medications (Drug)
Arm 4
sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
干预措施: sotrastaurin (300 mg bid) + tacrolimus + standard of care medications (Drug)
结局指标
主要结局
Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.
时间窗: Month 6
次要结局
- Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine).(Months 3, 6, 12, and 24)
- Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms.(Months 12, 24)
- Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant(Months 6, 12, 24)
- Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination).(Months 3, 6, 12, 24)