Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Renal Function (Nankivell Formula) at Month 12 Post Transplantation.
研究概览
简要总结
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.
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 65 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
- •The following exclusion criteria must not be present at BL 1 (Screening visit prior to transplantation):
- •More than one previous renal transplantation
- •Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
- •Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
- •Patients who are recipients of A-B-O incompatible transplants
- •Patients with a historical or current peak PRA of > 25%
- •Patients with already existing antibodies against the HLA-type of the receiving transplant
- •Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
- •Of all patients included into the study at BL 1 (prior to transplantation), those who met one or more of the following criteria at BL 2, prior to randomization, should not continue into the randomized study period:
- •Graft loss or death
- •Changes to the immunosuppressive regimen prior to randomization due to immunologic reasons
- •Patients who suffered from severe rejection (>= BANFF II acute rejection), recurrent acute rejection, or steroid resistant acute rejection
- •Proteinuria > 1g/day
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Everolimus + Mycophenolate sodium
Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
干预措施: Everolimus (Drug)
Everolimus + Mycophenolate sodium
Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
干预措施: Enteric-coated mycophenolate sodium (Drug)
Everolimus + Mycophenolate sodium
Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
干预措施: Corticosteroids (Drug)
Cyclosporine + Mycophenolate sodium
Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
干预措施: Cyclosporine (Drug)
Cyclosporine + Mycophenolate sodium
Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
干预措施: Enteric-coated mycophenolate sodium (Drug)
Cyclosporine + Mycophenolate sodium
Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Renal Function (Nankivell Formula) at Month 12 Post Transplantation.
时间窗: at Month 12 post transplantation
Renal function at the end of the trial assessed as mean absolute values of the glomerular filtration rate (GFR) calculated by Nankivell formula 12 months after renal transplantation. The Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)\^2 + C ; where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. Estimated GFR is expressed in mL/min per 1.73m\^2.
次要结局
- Number of Participants With Occurrence of Treatment Failures(up to or at Month 12)
- Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death(Up to Month 12)
- Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12(Month 4.5 and Month 12)
- Number of Participants Who Experienced an Adverse Event or Serious Adverse Event(Aes from end of core study period (month 12) to end of follow-up period (month 60))