EUCTR2013-001798-26-FR进行中（未招募）1 期
A multicenter, open-label, Prospective, randomized parallel group Phase III study investigating the benefit on Renal function of a CNI-free regimen with MyfOrtic® (mycophenolate sodium) and Certican® (everolimus) in coMparison to therapy with CErTican® (everolimus) and Prograf® (tacrolimus) in de novo rEnal transplant patients at 12 months post transplantation
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
- 390
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)Males or females, aged = 18 years and = 65 years
- •2)End stage kidney disease and a suitable candidate for primary renal transplantation
- •3)Receiving a kidney transplant from a deceased or living donor
- •4)Female capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 8 weeks following discontinuation of study medication even where there has been a history of infertility
- •5)Total ischemia time below 30 hours.
- •6)Patients able to receive a first dose of tacrolimus and everolimus in the 24 hours following the reperfusion of the transplant.
- •7)Capable of understanding the purpose and risks of the study.
- •8)Fully informed and having given written informed consent (signed Informed Consent has been obtained).
- •9)Affiliation to the social security regimen
- •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 390
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)More than one previous renal transplantation
- •2)Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ, different from kidney
- •3)Patients receiving a kidney from a non-heart beating donor
- •4)Patients who are recipients of A-B-O incompatible transplants
- •5)Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors with positive test for Hepatitis B surface antigen or Hepatitis C are excluded.
- •6)Patients who have been treated with one of the study drug for 4 weeks before Everolimus administration.
- •7)Patients with clinically significant infection requiring continued therapy which would interfere with the objectives of the study
- •8)TGI > 50%
- •9)Known allergy or contraindication to everolimus, tacrolimus, mycophenolic acid, basiliximab, corticosteroids or any of the product excipients.
- •10)Evidence of severe liver disease (incl. abnormal liver enzyme profil, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •11)Severe hyperlipidemia defined by: total cholesterol = 9,1 mmol/L (= 350 mg/dL) and/or hypertriglyceridemia = 5,6 mmol/l (= 500 mg/dL)
- •12)Patients with leucopenia (leucocytes = 3000 / mm3) or thrombocytopenia (platelets = 75000/mm3)
- •13)Patients having cicatrisation problems.
- •14)Patients suffering from a peptic ulcer.
- •15)Currently participating in another clinical trial, and/or has taken an investigational drug within four weeks prior to enrollment.
- •16)Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
- •17)Unlikely to comply with the visits scheduled in the protocol.
- •18)Patients with a diagnosed cancer or history of cancer (except for basal-cell carcinoma) within 5 years prior to enrollment
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