NCT00443937已完成4 期
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Stable Renal Transplant Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range
研究概览
简要总结
Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are
- To determine the influence of CNI discontinuation on the drug exposure and key pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium (EC-MPS)
- To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen
- To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety (e.g. rejection rates) and tolerability
- To investigate renal function after CsA withdrawal
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
- Treatment
- 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
- •Patients having a kidney transplant since at least 6 months but for no longer than 5 years.
- •Patients in a stable condition in terms of graft function
- •Patients currently receiving EC-MPS and CsA with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month prior to Baseline
- •Females of childbearing potential must have a negative serum pregnancy test prior to study inclusion. If positive, the patient will not be enrolled. Effective contraception must be used during the trial.
排除标准
- •Patients with any known hypersensitivity to EC-MPS or everolimus or other components of the formulation (e.g., lactose)
- •Patients with a history of severe rejection (according to BANFF criteria) within 3 months of enrollment in this trial.
- •Changes to the immunosuppressive regimen during the last 3 months due to immunologic reasons.
- •Patients with thrombocytopenia (platelets <100,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (leukocytes <4,500/mm3), and/or hemoglobin <9.0 g/dL at baseline.
- •Patients with proteinuria at baseline (> 1g/d)
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range
时间窗: 7 days
Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12
时间窗: 1 year
次要结局
- Safety and tolerability of the treatment regimen consisting over a one year period(1 year)
- Renal function during the course of the trial, especially after CNI withdrawal.(1 year)
- Routine laboratory parameters during the course of the trial.(1 year)
研究者
研究点 (2)
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