Research on individualisation of tacrolimus regimen based on the CYP3A5, MDR1 and PXR genotype-guided combination therapy (coadministration with diltiazem or Schisandra sphenanthera extract): a randomised controlled trial

Sun Yat-sen University (China)0 个研究点目标入组 500 人开始时间: 2009年9月23日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Adult (both males and females, 18-60 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University
•2. Only for retrospective study: Used a triple regimen with tacrolimus, mycophenolate mofetil and prednisone after transplantation (Note: In prospective study, patients were enrolled before immunosuppresants were used)
•3. Wish to participate in the study
•4. Informed consent for the trial

•1. Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus
•2. Patients with ABO-incompatible renal transplantation
•3. Panel reactive antibody (PRA) levels greater than 30% before transplantation
•4. Underwent combined organ transplantations
•5. Except for diltiazem and SchE, other medication known to affect tacrolimus blood levels, such as verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used
•6. Allergic history to study medicines
•7. During pregnancy or plan to get pregnant during the study period

发起方

Sun Yat-sen University (China)