Once-a-day regimen or Steroid withdrawal in de novo kidney transplant recipients treated with everolimus, cyclosporin and steroids: a 12-month, prospective, randomized, multicenter, open-label study. The EVIDENCE study (EVerol/mus once-a-Day rEgimen with Neoral versus Corticosteroid Elimination). - EVIDENCE

OVARTIS FARMA0 个研究点开始时间: 2009年3月12日最近更新: 2013年6月17日

试验速览

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•Males or females, >18 years of age at transplant; Recipients of 1st or 2nd single kidney transplant; Donor age >14 years; Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline (Visit 2), and are required to practice an approved method of birth control for the duration of the study and for a period of 2 months following discontinuation of study medication; Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
•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

•recipients of kidney-pancreas transplant, double kidney or any other transplant; recipients of a 2nd kidney transplant who lost the 1st for immunological reasons; Focal segmental glomerulosclerosis (FSGS), primary oxaluria or other diseases (as cause of end stage renal failure - ESRF) at high risk of rapid recurrence or requiring continuous corticosteroid treatment; Recipients of A-B-O incompatible transplants; Historical or current peak PRA of > 25% (current = 3 months); Patients with already existing antibodies against the donor; Thrombocytopenia (platelets < 75,000/mm³), absolute neutrophil count of <1,500/mm³, leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL; Symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, or to comply with the study requirements, or to give informed consent; History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; Patients who are HIV positive or Hepatitis B surface antigen positive (HbsAg); HCV positive patients receiving interferon and/or ribavirin; Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL); Evidence of drug or alcohol abuse; Body mass index (BMI) > 35;

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