EUCTR2005-003383-39-ES进行中（未招募）1 期
A randomized, open-label, multi-center study comparing a steroid sparing regimen versus standard steroid regimen in combination with daclizumab, mycophenolate mofetil and sirolimus in the prevention of acute renal allograft rejection.Estudio abierto, aleatorizado, multicéntrico, nacional, comparando un régimen libre de esteroides frente a un régimen de esteroides estándar, en combinación con Daclizumab, Micofenolato Mofetil y Sirolimus, en la prevención del rechazo agudo en trasplante renal.
Roche Farma S.A.0 个研究点目标入组 144 人开始时间: 2005年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •–Patients who are males or non-pregnant females > 18 years old.
- •–Patients who are recipients of primary kidney allografts.
- •–Patients who are single-organ recipients (kidney only).
- •–Patients with PRA <20%
- •–If patients are women of childbearing potential, they must have a negative pregnancy test, and use a reliable form of contraception
- •–Patients and their guardians must be capable of understanding the purpose and risks of the study.
- •–Patients who are willing to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •–Patients previously treated with Daclizumab, MMF or SRL.
- •–Patients who require in addition to the study immunosuppresive regimen anti-lymphocyte preparations for induction therapy.
- •–Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method during the study.
- •–Patients with severe gastrointestinal disorders that interfere with
- •Their ability to receive or absorb oral medication and patients with severe diarrhoea.
- •–Patients who are expected than to require oral corticosteroids post-transplant (i.e. patients suffering autoinmune diseases).
- •–Patients with active peptic ulcer disease.
- •–Patients receiving bile-acid sequestrants.
- •–Patients with severe anemia (Hb<6 g/dl), leucopenia (WBC<2500/mm3) or thrombocytopenia (Tc<100’000/mm3)
- •–Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- •–HIV positive donor or patient
- •–Patients with history of malignancy within the last 5 years, except localised and treated non melanoma skin cancer, treated and without recidive evidence.
- •–Patients for whom the investigator considers a treatment with the following medications necessary:
- •?Azathioprine,
- •?methotrexate
- •?cyclophosphamide,
- •?Cyclosporine
- •?Tacrolimus
- •?Everolimus
- •?Mycophenolate sodium
- •?polyclonal and monoclonal anti-lymphocyte antibodies other than daclizumab (e.g. OKT3, ATG, basiliximab)
- •–Known hypersensitivity or absolute contraindications to any of the medications administered in the context of the study or any other substances present in the study medications
- •–Patients who require concomitant treatment with other investigational or prohibited drugs.
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