A Scandinavian Controlled, Randomized, Open-label, and Multi-centre Study Evaluating if Once-daily Tacrolimus or Twice-daily Cyclosporin, Reduces the 3-year Incidence of Chronic Lung Allograft Dysfunction After Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 249
- 试验地点
- 5
- 主要终点
- Number of patients with incidence of CLAD
研究概览
简要总结
A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after lung transplantation, in comparison with a standard cyclosporin-based protocol.
详细描述
Study purpose:
To evaluate whether the use of a once-daily tacrolimus-dose regimen (Advagraf®), based on anti-thymocyte globulin (Thymoglobulin®) induction, mycophenolate mofetil (MMF) and corticosteroids, reduces the cumulative incidence of CLAD after de novo lung transplantation at 36 months, in comparison with a twice-daily cyclosporin-based protocol, otherwise identical between groups.
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
Arm A:Cyclosporine
Group A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.
干预措施: Cyclosporine (Drug)
Arm A:Cyclosporine
Group A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.
干预措施: Mycophenolate mofetil (MMF) (Drug)
Arm A:Cyclosporine
Group A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.
干预措施: Rabbit Anti thymocyte globulin (Drug)
Arm A:Cyclosporine
Group A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.
干预措施: Corticosteroids (Drug)
Arm B:Tacrolimus
Group B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.
干预措施: Mycophenolate mofetil (MMF) (Drug)
Arm B:Tacrolimus
Group B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.
干预措施: Rabbit Anti thymocyte globulin (Drug)
Arm B:Tacrolimus
Group B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.
干预措施: Corticosteroids (Drug)
Arm B:Tacrolimus
Group B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Number of patients with incidence of CLAD
时间窗: 72 months is outcome for continuation study
The cumulative incidence of CLAD (including both BOS and RAS, as defined by the Appendix II) at 72 months after lung transplantation.
次要结局
- Renal function mGFR(36 months)
- Patient survival(3 year)
- Cumulative incidence of acute allograft rejection and CLAD(3 year)
- Proteinuria(36 months)
- Lipid profile(36 months)
- Primary graft dysfunction(72 hours)
- Safety and tolerability(0-36 months)
- Quality of life assessed by EQ5D Questionnaire(12 months)
- Glomerular Filtration Rate(3 months)
- Composite measure of freedom from AR, CLAD, graft and patient survival(36 months)
- Incidence of primary graft dysfunction(72 hours)
- Cumulative incidence of BOS and RAS(3 year)
- Development of donor specific antibodies(36 months)
- Renal function cGFR(36 months)
- Post Transplantation Diabetes Mellitus(36 months)
- Antidiabetic medication(36 months)
- Antihypertensive and lipid lowering drugs(36 months)
- Malignancy stratified by post-transplant lymphoproliferative disorder (PTLD) and all other cancers.(36 months)
- Quality of life, assessed by St Georges Respiratory Questionnaire (SGRQ)(36 months)
- Cytomegalovirus(0-36 months)
- Quality of life assessed by St Georges Respiratory Questionnaire (SGRQ)(12 months)
- Pharmacokinetics of the Tacrolimus drug in patients in the CF sub group(6 months)
- Immunological equipotency of tacrolimus and cyclosporine A(0-36 months)
- Occurrence of treatment failures(0-36 months)
- Quality of life, assessed by EQ5D Questionnaire(24 months)
- Quality of life, assessed by EQ5D Questionnaire (SGRQ)(36 months)
- Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population(week 4)
- Recovery of right heart function(0-36 months)
研究者
Göran Dellgren
MD, PhD
Vastra Gotaland Region