NCT00239044已完成3 期
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
研究概览
简要总结
To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged between 18 and 80 years.
- •Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
- •Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
- •Patients receiving MMF at reduced dose prior to study entry
- •Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
- •Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
- •Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
排除标准
- •Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
- •Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
- •Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
- •Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<2,500/mm3), and/or hemoglobin <6.0 g/dL prior to enrollment.
- •Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
- •Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- •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
- •Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
- •Known positive HIV and/or Hepatitis B surface antigen positive.
- •Evidence of drug and/or alcohol abuse.
结局指标
主要结局
Adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen .
次要结局
- Pharmacokinetic profiles of MMF and EC-MPS.
- Patient and graft survival, graft function
- Safety
研究者
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