NCT02160054已完成不适用
Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 30
- 主要终点
- Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
研究概览
简要总结
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
- •Patients who meet one or more of following criteria
- •Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision
- •Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug
- •Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug
- •Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision
- •Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision
排除标准
- 未提供
研究组 & 干预措施
Group 1
patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ®
干预措施: Graceptor® (Drug)
结局指标
主要结局
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
时间窗: 12 months
次要结局
- Renal function, hypertension, hyperlipidaemia, other adverse events(12 months)
研究者
研究点 (30)
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