EUCTR2014-005572-28-FR进行中（未招募）1 期
Open-label, Multicentre, Randomized Clinical Trial To Compare The Pharmacokinetics Of Envarsus® Tablets And Advagraf® Capsules Administered Once Daily In Adult De-novo Kidney Transplant Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Subject's written informed consent obtained prior to any study-related procedure;
- •2. Adult caucasian male and female patients at least 18 years of age;
- •3. Recipients of a kidney transplant from a deceased donor or a living donor including patients undergoing a second kidney transplant.
- •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 48
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. For female subjects, pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the reliable methods of contraception;
- •2. Recipient of any transplanted organ other than a kidney;
- •3. Recipients of a bone marrow or stem cell transplant;
- •4. Recipients of a kidney from a cardiac death donor;
- •5. Recipients of a kidney from an ABO incompatible donor;
- •6. Recipients with TGI (Taux de Greffons Incompatibles histories, i.e. rate of graft incompatible among donors over the past 5 years) > 85% and/or having pre-transplant donor-specific anti-HLA antibodies (DSA);
- •7. Recipients of a kidney with an anticipated cold ischemia time = 24 hours;
- •8. Recipients positive for Hepatitis C virus (HCV-RNA positive) and/or Hepatitis B Virus (HBV-DNA or HBsAg positive)*;
- •9. Recipients positive for Human Immunodeficiency Virus (HIV-Ab positive)*;
- •10. Patients with a current malignancy or a history of malignancy ;
- •11. Patients with an uncontrolled concomitant infection;
研究者
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