EUCTR2005-000380-26-ES进行中（未招募）1 期
A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients - CERTES02
ovartis Farmacéutica S.A.0 个研究点目标入组 0 人开始时间: 2006年5月9日最近更新:
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试验速览
- 阶段
- 1 期
- 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
- •Each patient must meet all of the following inclusion criteria:
- •1. Male or female patients between 18 and 65 years of age
- •2. Male or female patients who are recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor .
- •3. The renal cold ischemic time (CIT) must be < 36 hours
- •4. The age of the donor must be < 65 years
- •5. Females of childbearing potential must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication.
- •6. Patients who have given written informed consent to participate in the study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria at baseline will be excluded from study participation.
- •1. Patients who are recipients of multiple organ transplants including any organ other than kidney
- •2. Patients who have been previously transplanted with any organ other than a kidney
- •3. Recipients of non heart-beating donor organs
- •4. Patients with current or past panel reactive T-cell antibodies (PRA) titers of >50%
- •5. Patients that had been treated with any investigational drug 4 weeks before the baseline period
- •6. Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to RAD001 (e.g. macrolides)
- •7. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment in this trial
- •8. Evidence of liver dysfunction as indicated by an abnormal liver profile (AST, ALT, alkaline phosphatase or total bilirubin = 3 times ULN) before transplantation
- •9. Patients who are known to have a positive hepatitis C serology, who are human immunodeficiency virus (HIV) or hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to randomization are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- •10. Patients with symptoms of significant somatic or mental illness. Unresolved history of drug or alcohol abuse
- •11. Presence of revascularized ischemic heart disease or AMI, (or any cardiac disease considered to be unsafe for the study by the investigator)
- •12. Presence of severe hypercholesterolemia (= 350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia (= 500mg/dL, 5.6 mmoL/L). Patients with controlled hyperlipidemia are acceptable
- •13. White blood cell (WBC) count= 3,500/mm3, or platelet count = 100,000/mm3
- •14. Patients with severe systemic infections
- •15. Patients with current or past malignancies (except for successfully treated localized basal cell carcinoma of the skin)
- •16. Patients who are recipients of A-B-O incompatible transplants or T-cell cross-match positive transplants
- •17. Patients with coagulopathy or any medical condition requiring long-term anticoagulation after transplantation (low dose aspirin is allowed)
- •18. Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to baseline visit, which at investigators discretion would interfere with the objectives of the study
- •19. Breast feeding women
- •20. Inability to cooperate or communicate with the investigator
- •21. Patients who have been treated with non-protocol immunosuppressive drug or treatment within 4 weeks prior to baseline visit
- •Exclusion criteria for randomization at the end of month 3 (week 12):
- •1. Any episode of acute rejection grade IIb/III (Banff classification) or a vascular acute rejection in the previous 4 weeks or any episode of acute rejection episode during the month prior to randomization.
- •2. Patients depending on dialysis
- •3. Serum creatinine >3 mg/dL and/or more than 30% elevated during the previous month.
- •4. Patients who do not tolerate any increase in Certican ® dose.
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