A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
研究概览
简要总结
This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.
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
- •Primary donor kidney transplant
- •Panel reactive antibody (PRA) ≤ 20%
排除标准
- •Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
- •Non-heart beating donor or kidney from a non-compatible donor
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Without Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
干预措施: Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
With Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
干预措施: Enteric-coated mycophenolate sodium (EC-MPS) (Drug)
With Steroids
Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
时间窗: 6 months post transplantation
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
次要结局
- The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months(Month 6)
- Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months(Month 3)
- Number of Participants With Subclinical Histological Rejections(Month 3)
- Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status(Month 3)
- Number of Participants Requiring Steroids in Non-steroid Treatment Group(Months 3 and 6)