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 (CAEB071A2214) - CAEB071A2214

ovartis0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Male or female patients >= 18 years old.
•Recipients of a first or second kidney transplant from a deceased, living unrelated or non- 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.

•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 increased cardiac risk: long QT-syndrome or QTcF at baseline exceeding 500 msec, or treatment with drugs inducing QT prolongation, class 1a and class 3 antiarrhythmic drugs, family history of long QT syndrome or of sudden unexplained death, history, in the preceding 3 months of significant and persistent arrhythmias, symptomatic/unstable coronary artery disease requiring hospitalization or a revascularization procedure in the 30 days prior to randomization, chronic heart failure which required hospitalization in the 30 days prior to randomization.
•High immunological risk.

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