Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
A 12-month, Multicenter, Randomized, Open-label Non-inferiority Study of Renal Function and Efficacy Comparing Concentration-controlled Certican (1.5 mg/Day Starting Dose) With Reduced Neoral Dose Versus MMF With Standard Neoral Dose in de Novo Heart Transplant Recipients
This study will test the safety and efficacy of everolimus on heart transplant recipients.
This study is not recruiting in the United States.
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
- Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
- Patients who have given written informed consent to participate in the study.
Exclusion Criteria:
Patients who are recipients of multiple solid organ transplants or have previously received organ transplants.
Patients who received any investigational drug or who have been treated with an immunosuppressive drug or treatment within 1 month prior to randomization Patients receiving induction therapy which is not standard per local practice Patients with donor greater than 60 years and/or with known donor coronary or heart disease at the time of transplant.
Donor heart cold ischemic time >6 hours. Patients with Panel Reactive Antibodies >20%. Patients who are recipients of ABO incompatible transplants Patients with platelet count <50,000/mm3 at the evaluation before randomization.
Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) Patients with an absolute neutrophil count of ≤1,500/mm3 or white blood cell count of ≤4000/mm3 at baseline before surgery Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed) Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.
Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded Patients with a known hypersensitivity to similar drugs and to the components of the formulations Patients being treated with terfenadine, astemizole, or cisapride. Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.
Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) Patients with clinically significant systemic infection Patients who are unable to take oral medication Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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compare renal function
|
次要结果测量
结果测量 |
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compare rates of acute rejection, efficacy and safety
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合作者和调查者
调查人员
- 学习椅:Basel Novartis Pharma AG、Basel Novartis Pharma AG
出版物和有用的链接
一般刊物
- Lehmkuhl et al., Transplantation, Volume 88, Number 1, July 15, 2009
- Vigano M, Dengler T, Mattei MF, Poncelet A, Vanhaecke J, Vermes E, Kleinloog R, Li Y, Gezahegen Y, Delgado JF; RAD A2411 Study Investigators. Lower incidence of cytomegalovirus infection with everolimus versus mycophenolate mofetil in de novo cardiac transplant recipients: a randomized, multicenter study. Transpl Infect Dis. 2010 Feb;12(1):23-30. doi: 10.1111/j.1399-3062.2009.00448.x. Epub 2009 Sep 9.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
依维莫司的临床试验
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Universitaire Ziekenhuizen KU Leuven完全的