NCT01353417已完成不适用
A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Changes in Adport Sandoz© trough level
研究概览
简要总结
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 18
- •Post renal transplantation time: ≥ 6 months
- •Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days)
- •Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS)
- •Written and oral informed consent
排除标准
- •Well-known poor compliance with immunosuppressives
- •Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months
结局指标
主要结局
Changes in Adport Sandoz© trough level
时间窗: Observation time: 26 weeks
次要结局
- Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels(Observation time: 26 weeks)
- Incidence of serious adverse drug reactions(Observation time: 26 weeks)
- Incidence of adverse drug reactions(Observation time: 26 weeks)
- Incidence of serious adverse events(Observation time: 26weeks)
研究者
研究点 (1)
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