EUCTR2009-015456-14-BE进行中（未招募）1 期
A partially blinded, prospective, randomized multicenter study evaluating efficacy, safety and tolerability of oral sotrastaurin plus standard or reduced exposure tacrolimus vs. myfortic plus tacrolimus in de novo renal transplant recipients - A2214
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients = 18 years old.
- •Recipients of a first or second kidney transplant from a deceased, living unrelated or non-human leukocyte antigen (HLA) identical living related donor.
- •Recipients of a kidney with a cold ischemia time < 30 hours.
- •Recipients of a kidney from a donor 10 – 65 years old.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Recipients who are unable to receive the first dose of oral study medication within 24 hours after allograft reperfusion.
- •Multi-organ transplant recipients.
- •Recipients of an organ from an non-heart beating donor.
- •Patients receiving a second kidney allograft if the first allograft was functional for less than three years (unless lost due to surgical complication).
- •Patients who are treated with drugs that are strong inducers or inhibitors of CYP3A4 at screening and cannot discontinue this treatment.
- •Patients with long QT-syndrome, or QTcF at baseline exceeding 500 msec, or who are treated with drugs inducing QT prolongation at screening, and cannot discontinue this treatment.
- •Patients requiring antiarrhythmic drugs with QT-prolonging properties (class 1a and class 3).
- •Patients with a family history of long QT syndrome or of sudden unexplained death.
- •Patients with a history, in the preceding 3 months of significant and persistent arrhythmias such as ventricular fibrillation or tachycardia, atrial fibrillation or flutter.
- •Patients with symptomatic/unstable coronary artery disease (i.e. angina, untreated cardiac atherosclerotic disease) requiring hospitalization or a revascularization procedure in the 30 days prior to randomization.
- •Patients with chronic heart failure which required hospitalization in the 30 days prior to randomization.
- •Patients at high immunological risk, e.g., sensitized patients (most recent anti-HLA class I panel reactive antibodies (PRA) > 20% by a CDC-based assay or > 50% by a flow cytometry, Luminex or enzyme linked immunosorbant assay (ELISA)).
研究者
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