EUCTR2007-000054-31-IT进行中（未招募）不适用
An Open-Label, Phase IV, Multi-Centre Study to Investigate theLong-Term Safety and Efficacy of Subcutaneous Dynepo in AdultPatients with Anaemia Associated with Chronic Kidney Disease. - SPD490-402
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Shire
- 入组人数
- 416
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
- •1. Patients who complete Dynepo study SPD490-301.
- •2. 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.
- •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
- •1. Withdrawal, before Week 24, from study SPD490-301.
- •2. Pregnant or lactating women.
- •3. Uncontrolled hypertension.
- •4. Thrombocytopenia (platelet count <75,000/mm3).
- •5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
- •6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days
- •immediately prior to enrolment in this study.
- •7. Androgen therapy in the 30 days immediately prior to enrolment in this study.
- •8. Known Human Immunodeficiency Virus (HIV) infection.
- •9. History of hypersensitivity to Dynepo.
- •10. Known to have Ab against EPO.
研究者
相似试验
进行中（未招募）
不适用
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. - Dynepo long-term safety studyAnaemia in Chronic Kidney Disease (CKD)EUCTR2007-000054-31-LVShire416
进行中（未招募）
1 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. - Dynepo long-term safety studyEUCTR2007-000054-31-FRShire416
进行中（未招募）
不适用
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. - Dynepo long-term safety studyAnaemia in Chronic Kidney Disease (CKD)EUCTR2007-000054-31-ATShire416
进行中（未招募）
不适用
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. - Dynepo long-term safety studyEUCTR2007-000054-31-BEShire Pharmaceutical Contracts Ltd416
进行中（未招募）
1 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. - Dynepo long-term safety studyAnaemia in Chronic Kidney Disease (CKD)EUCTR2007-000054-31-GBShire416