EUCTR2011-000691-34-ES进行中（未招募）1 期
Single-center pilot study, prospective, open-label, to evaluate the efficacy and safety of immunosuppression low nephrotoxicity, based on the use of ATeGe-Fresenius in patients with renal insufficiency pretransplant liver
Dra Itxarone Bilbao. Servicio de Cirugía Hepatobiliopancreatica y Trasplantes. HUVH.0 个研究点目标入组 40 人开始时间: 2011年7月21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
- 40
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
- •Pacientes que vayan a ser sometidos a un primer trasplante hepático de 18-70 años de edad, sin contraindicación a priori para la realización de biopsias del aloinjerto, y con insuficiencia renal, que presenten niveles de creatinina sérica superiores a 1,5 mg/dl antes del trasplante hepático o valores de aclaramiento de creatinina estimado por MDRD <60ml/min
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Pacientes receptores de trasplante de múltiples órganos o con antecedentes de trasplante previo de cualquier otro órgano, receptores de un trasplante hepático procedente de un donante en asistolia o con incompatibilidad ABO respecto al donante, con infecciones concomitantes no controladas significativas y/o diarrea, vómito o úlcera péptica activa graves, recepción de vacunas con virus atenuados en las semanas previas al trasplante, leucopenia, trombocitopenia, y recuento linfocitario CD2+/CD3+ inferior a 10 células/μl.
研究者
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