Identification of a specific systemic transcriptome able to differentiate patients with renal transplantation in chronic treatment with tacrolimus from those with mTOR inhibitors. - NA

Azienda Ospedaliera Universitaria Integrata Verona0 个研究点目标入组 40 人开始时间: 2014年2月19日最近更新: 2015年3月9日

适应症

试验速览

暂无简介。

•Written informed consent
•age > 18 years
•first renal transplantation
•renal transplantation performed since more than 6 months at the time of enrollment
•estimated GFR (as assessed by the use of the equation aMDRD) greater than 30 mL / min
•Chronic treatment with tacrolimus or mTOR inhibitors (everolimus, sirolimus) in
•combination with mycophenolate mofetil (MMF) since more than 6 months
•Blood levels between 4-8 ng/ml (Tacrolimus) and 4-8 ug/L (inhibitors
•Chronic treatment with corticosteroid (prednisone 5 mg or 4 mg of methylprednisolone)
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Patients participating in another study
•Change in GFR> 30% in the 6 months prior to enrollment
•Diagnosis and treatment of acute rejection in the 6 months prior to enrollment
•other solid organ transplantation in combination with renal transplantation
•Malignant neoplasm in the active phase (excluding non-melanoma skin cancer)
•Hemodialysis
•Severe acute and chronic liver disease (hepatitis B virus-related, hepatitis C virus-related, toxic,
•immunoallergic)
•Women with a positive pregnancy test at enrollment
•Pregnant or breastfeeding women or women not using effective contraception if
•they are of childbearing age.
•planned surgery during the study period (with the exception of an cataract surgery, vascular surgery, removal of urethral stent, tube replacement
•nephrostomy, minor surgery in an outpatient surgery that does not require
•hospitalization)
•HIV infection

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