NCT00150046已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- compare renal function
研究概览
简要总结
This study will test the safety and efficacy of everolimus on heart transplant recipients.
This study is not recruiting in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 3A
- •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
结局指标
主要结局
compare renal function
次要结局
- compare rates of acute rejection, efficacy and safety
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) AvoidanceRenal Function and Chronic Allograft VasculopathyNCT01266148Novartis Pharmaceuticals115
Unknown
4 期
Study to Evaluate the Safety and Efficacy of Switching Calcineurin Inhibitor to Everolimus After Kidney Transplantation in AdultsKidney TransplantImmunosuppressionNCT01455649Deise de Boni Monteiro de Carvalho30
已完成
2 期
Safety and Tolerability of Everolimus as Second-line Treatment in Poorly Differentiated Neuroendocrine Carcinoma / Neuroendocrine Carcinoma G3 (WHO 2010) and Neuroendocrine Tumor G3 - an Investigator Initiated Phase II StudyPoorly Differentiated Malignant Neuroendocrine CarcinomaNeuroendocrine Carcinoma, Grade 3Neuroendocrine Carcinoma, Grade 1 [Well-differentiated Neuroendocrine Carcinoma] That Switched to G3Neuroendocrine Carcinoma, Grade 2 [Moderately Differentiated Neuroendocrine Carcinoma] That Switched to G3Neuroendocrine Tumor, Grade 3 and Disease Progression as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.)NCT02113800AIO-Studien-gGmbH40
Unknown
4 期
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to EverolimusKidney Transplant RecipientsNCT01608412Hospital de Clinicas de Porto Alegre120
已完成
2 期
Study to Collect and Assess Long-term Safety of Everolimus in Patients Who Are on Everolimus Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator.NeoplasmsNCT02017860Novartis Pharmaceuticals4