EUCTR2016-000404-28-SE进行中（未招募）1 期
5, 6 or 7 year follow-up control after the SCHEDULE study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE) Title of the original SCHEDULE study:A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®) and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy.(Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41) - 5, 6 or 7 year follow-up control after the SCHEDULE study
ovartis Norge AS0 个研究点目标入组 115 人开始时间: 2016年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
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
- •Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit,
- •Patients who, and are coming for a regularan annual clinic visit 5 or to 7 years after randomization in the main study
- •Obtaining of a will be asked to participate in this 5 to 7-year follow-up examination. A separate signed patient informed consent will be required for participation in this follow-up examination.
- •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 85
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients with a retransplanted heart since the original SCHEDULE study.
研究者
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