NCT00312143已完成4 期
A Prospective, Open Label, Multicenter Study to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 35
- 主要终点
- patient and graft survival
研究概览
简要总结
This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 to 75 years.
- •Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
- •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 recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
- •Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
- •Patients with low platelet count (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at screening or baseline.
- •Patients who have received an investigational drug within four weeks prior to study entry.
- •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.
- •Additional protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
patient and graft survival
acute rejection incidence
graft function at 6 months post transplant.
次要结局
- influence of age, gender, and post-transplantation complications on the main clinical outcomes
研究者
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