Efficacy and Safety of Maintenance Neoral Compared to Bitherapy Neoral-Imurel or Neoral-CellCept in Renal Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 10
- 主要终点
- to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
研究概览
简要总结
We have previously defined factors that predict the long term success of maintenance CsA monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We have also shown that the 8-year graft survival in 329 selected patients enrolled in maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332). These results were obtained with an old formulation of cyclosporin, azathioprine, steroid withdrawal over the first year and induction antibody. This prospective randomized multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological risk cadaveric kidney transplant recipients.
详细描述
Between july 1998 and january 2004 selected patients were randomly assigned equally within each centre to receive CsAm or bitherapy with equally CsA + MMF or CsA + AZA.
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
- 25 Years 至 —（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
- •Living donor transplantation
- •Recipient receiving tacrolimus
- •Azathioprine intolerance
- •Thrombopenia < 100 000/mm³
- •Neutropenia < 1500/mm³
- •Hemoglobinemia <= 8g/dl
- •On going infection
结局指标
主要结局
to compare maintenance CsAm with dual therapy groups and within dual therapy MMF with AZA for :
The incidence and the delay of occurrence of graft dysfunction episode defined as ³ 20 % increase in serum creatinine level (mean of three results obtained in the same laboratory) and requiring a graft biopsy.
Causes of graft dysfunction episodes diagnosed by graft biopsy.
The incidence of serious infections (HVZ, EBV, HPV genital infection, febrile UTI, pneumonitis...)
次要结局
- To compare the three treatment groups for the following parameters :
- Incidence of therapeutic failure defined by biopsy proven acute rejection episode or CsA renal toxicity
- Graft function evaluated by serum creatinine level and calculated creatinine clearance (CG formula)
- Adverse events
- Patient and graft survival