EUCTR2004-001052-36-DE进行中（未招募）不适用
A 12-month, multi-center, 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. - RAD2411
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
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
- •Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation.
- •Patients who have given written informed consent to participate in the study.
- •Calculated creatinine clearance (by Cockroft-Gault) = 50 mL/min at screening
- •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 with platelet count <50,000/mm3 at the evaluation before randomization.
- •Patients who are recipients of multiple solid organ transplants.
- •Patients receiving induction therapy which is not standard per local practice
- •Patients with clinically significant systemic infection.
- •Patients receiving investigational agents in the 30 days prior to study entry.
- •Known hypersensitivity to drugs of this class.
- •Donor > 60 years and/or with known donor heart disease
- •Patients with PRA >20%.
- •Treatment with strong inducers or inhibitors of cytochrome P450 3A4.
- •Cold ischemic time >6 hours.
- •Unable to take oral medication.
研究者
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