EUCTR2013-003195-12-FR进行中（未招募）不适用
A multicenter, two arms, randomized, open label clinical Phase IV study investigating the proportion of CMV seropositive kidney transplant recipients who will develop a CMV infection within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose of cyclosporine A (Néoral®). - EVERCMV
CHU de Bordeaux0 个研究点开始时间: 2015年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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)Age = 18 years
- •2)End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation
- •3)Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor
- •4)Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type
- •5)Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug
- •6)Total ischemia time below 36 hours
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)CMV seronegative patient
- •2)Historical or current TGI (French equivalence of calculated PRA) > 85 %
- •3)Presence of historical or current anti-HLA donor specific antibodies
- •4)Patient who received anti-CMV therapy within the past 30 days prior to screening
- •5)Receiving or having previously received an organ transplant other than a kidney
- •6)Receiving a graft from a non-heart-beating donor
- •7)Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels = 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor
- •8)Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
- •9)Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients
- •10)Severe hyperlipidemia defined by : total cholestérol = 9,1 mmol/L (= 350 mg/dL) et/ou triglycérides = 8,5 mmol/l (= 750 mg/dL) in spite an adequate medication
- •11)Patient has adequate hematological post-transplant defined as:
- •a) Absolute neutrophil count (ANC) > 1000 cells/µL
- •b) Platelet count > 50,000 cells/µL
- •c) Hemoglobin > 8.0 g/dL
- •12)Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG
- •13)Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criteria
- •14)Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
- •15)Unlikely to comply with the visits scheduled in the protocol
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