NCT00514813终止4 期
An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients who complete Dynepo study SPD490-
- •Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.
排除标准
- •Withdrawal, before Week 24, from study SPD490-
- •Pregnant or lactating women.
- •Uncontrolled hypertension.
- •Thrombocytopenia (platelet count <75,000/mm3).
- •Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
- •Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
- •Androgen therapy in the 30 days immediately prior to enrolment in this study.
- •Known Human Immunodeficiency Virus (HIV) infection.
- •History of hypersensitivity to Dynepo.
- •Known to have Ab against EPO.
研究组 & 干预措施
Dynepo (Epoetin delta)
Experimental
Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject
干预措施: Dynepo (Drug)
结局指标
主要结局
Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Over the course of 2 Years
次要结局
- Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years(Baseline and 2 years)
- Change From Baseline in Hematocrits at 2 Years(Baseline and 2 years)
研究者
研究点 (1)
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