5, 6 or 7 Year Follow-up Control After the SCHEDULE Study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Measured Glomerular Filtration Rate (mGFR)
研究概览
简要总结
The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.
详细描述
This protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month SCHEDULE (NCT01266148) study and the following 3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard immunosuppressive regimen including CsA, on renal and heart function. During the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).
Study code of SCHEDULE, the core study: CRAD001ANO02 (EudraCT No.: 2009-013074-41)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
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 are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study
- •Obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination.
排除标准
- •Patients with a retransplanted heart since the original SCHEDULE study
研究组 & 干预措施
EVEROLIMUS
patients received everolimus (Certican), low-exposure CsA (Neoral), mycophenolate mofetil (MMF) and corticosteroids with CsA withdrawal after 7-11 weeks
干预措施: Everolimus (Drug)
Control
patients received standard CsA, MMF and corticosteroids
干预措施: Cyclosporine (Drug)
Control
patients received standard CsA, MMF and corticosteroids
干预措施: Mycophenolate mofetil (Drug)
Control
patients received standard CsA, MMF and corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Measured Glomerular Filtration Rate (mGFR)
时间窗: at the 5-7 year follow-up visit
Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.
次要结局
- Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)(at the 5-7 year follow-up)
- Change From Baseline in Visual Analog Scale (VAS)(baseline, at the 5-7 year visit)
- Number of Participants With Beck Depression Inventory (BDI)(at the 5-7 year visit)
- Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)(within 5-7 years)
- Myocardial Structure and Function(within 5-7 years)
- Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up(at the 5-7 year visit)
- Change From Baseline in the Euro Quality of Life 5D(Baseline, 5-7 year visit)