EUCTR2008-005109-20-DE进行中（未招募）不适用
6-month, open-label, randomized, multicenter, prospective, controlled study to evaluate the efficacy, safety and tolerability of Everolimus in de novo renal transplant recipients participating in the Eurotransplant senior program - SENATOR
ovartis Pharma GmbH0 个研究点开始时间: 2009年3月27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.Males or females, aged > 65 years, receiving the first kidney from a donor aged > 65 years in the Eurotransplant Senior Program
- •2.Recipients of de novo cadaveric kidney transplants
- •3.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) no
- •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.Multi-organ recipients (e.g., kidney and pancreas)
- •2.Patients receiving a kidney from a non-heart beating donor
- •3.Patients who are recipients of A-B-0 incompatible transplants
- •4.Patients with a historical or current peak PRA of > 25% (current = 3 months)
- •5.Patients with already existing antibodies against the HLA-type of the receiving transplant
- •6.Patients with any known hypersensitivity to Simulect®, Certican®, mycophenolic acid, cyclosporine A, other drugs similar to Certican® (e.g., macrolides), or other components of the formulations (e.g. lactose)
- •7.Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
- •8.Patients with thrombocytopenia (platelets < 75,000/mm³), with an absolute neutrophil count of < 1,500/mm³ or leucopenia (leucocytes < 2,500/mm³), or hemoglobin < 6 g/dL
- •9.Patients with symptoms of significant somatic or mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent
- •10.Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
- •11.Evidence of severe liver disease (incl. abnormal liver enzyme profile, i.e. AST, ALT or total bilirubin > 3 times UNL)
- •12.Females at randomization who will be considered post-menopausal according to the following definition:
- •= 12 months of natural (spontaneous) amenorrhea or
- •= 12 month post surgical bilateral oophorectomy or
- •hysterectomized women over or equal to 65 years of age
- •13.Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study
- •14.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •15.Evidence of drug or alcohol abuse
- •16.Patients receiving drugs known to strongly interact with CsA and/or everolimus according to the list provided in Appendix 3 to this protocol should be excluded, if in the opinion of the investigator this drug interaction interferes with the objectives of the study, namely a clinical meaningful potentiation of renal dysfunction and/or maintenance of adequate immunosuppressive drug levels
研究者
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