An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
研究概览
简要总结
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- •Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type
排除标准
- •Patient has an immunological high risk, defined as having a most recently measured PRA grade of >= 50% within the previous six months
- •Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- •Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- •Patient or donor is known to be HIV positive
- •Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- •Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
- •Patient is receiving a graft from a non-heart-beating donor
- •Cold ischemia time of the donor kidney >= 40 hours
研究组 & 干预措施
1
Tacrolimus/MMF/steroids throughout the study
干预措施: Tacrolimus (Drug)
1
Tacrolimus/MMF/steroids throughout the study
干预措施: Mycophenolate Mofetil (Drug)
1
Tacrolimus/MMF/steroids throughout the study
干预措施: methylprednisolone and prednisone (Drug)
2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
干预措施: Tacrolimus (Drug)
2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
干预措施: Mycophenolate Mofetil (Drug)
2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
干预措施: methylprednisolone and prednisone (Drug)
结局指标
主要结局
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
时间窗: 6 months
次要结局
- Incidence and seriousness of adverse events(6 months)