SCHEDULE - 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
- 115
- 试验地点
- 1
- 主要终点
- Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation
研究概览
简要总结
A controlled, randomized, open-label, multicenter study evaluating if early initiation of everolimus and early elimination of cyclosporine in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy
详细描述
This was a prospective, multi-center, randomized, controlled, parallel group, open label study in de novo heart transplant recipients. Patients eligibility for randomization was assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion criteria were randomized to one of two treatment groups: either conventional treatment with Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was maintained in Group A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Everolimus
Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
干预措施: Cyclosporine (Drug)
Everolimus
Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
干预措施: Mycophenolate mofetil (Drug)
Everolimus
Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
干预措施: Corticosteroids (Drug)
Everolimus
Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
干预措施: Everolimus (Drug)
Everolimus
Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
干预措施: Anti Thymocyte Globulin (Drug)
Control
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
干预措施: Cyclosporine (Drug)
Control
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
干预措施: Mycophenolate mofetil (Drug)
Control
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
干预措施: Corticosteroids (Drug)
Control
Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
干预措施: Anti Thymocyte Globulin (Drug)
结局指标
主要结局
Measured Glomerular Filtration Rate (mGFR), 12 Months After Heart Transplantation
时间窗: Week 52
Measured Glomerular Filtration Rate (mGFR) describes the flow rate of filtered fluid through the kidney. GFR is equal to the clearance rate when any solute is freely filtered and is neither reabsorbed nor secreted by the kidneys. The rate therefore measured is the quantity of the substance in the urine that originated from a calculable volume of blood. Participants' urine was used for this assessment at week 52 after heart transplant.
次要结局
- Lipid Profile at 12 Months(52 weeks)
- Progression of Chronic Allograft Vasculopathy (CAV) Based on Maximal Intimal Thickness (MIT) From Baseline to Week 52(Baseline and week 52)
- Progression of Chronic Allograft Vasculopathy (CAV) Based on Incidence of Chronic Allograft Vasculopathy (CAV) From Baseline to Week 52(Baseline and week 52)
- Change in Calculated Glomerular Filtration Rate From Pre-transplantation to Week 52(Day 1, weeks 7 to 11(baseline) and of week 52)
- Occurrence of Treatment Failures up to 12 Months After Transplant(52 weeks)
- Average Level of Protenuria at Week 52(52 weeks)
- Calculated Glomerular Filtration Rate From Pre-Transplantation to Week 52(Day 1, weeks 7 to 11 and of week 52)
- Number of Rejections Leading to Hemodynamic Compromise(52 weeks)
- Change in Quality of Life Assessed by SF-36 (Minnesota Living With Heart Failure Questionnaire ([MLHF)]) From Pre-transplant to Week 52 of Treatment(Pre transplant and 52 weeks)
- Change in Quality of Life - Euro Quality of Life 5D (EQ-5D)(Pre transplant and 52 weeks)