An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 407
- 试验地点
- 53
- 主要终点
- Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
- •Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
- •Transferrin saturation >= 20% and ferritin >= 100 ng/mL.
排除标准
- •Uncontrolled hypertension.
- •Requiring doses of EPO > 10,000 IU/week.
- •Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
- •Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
- •Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
- •Androgen therapy in the 30 days immediately prior to randomisation in the study.
- •Known Human Immunodeficiency Virus(HIV)infection.
- •History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
研究组 & 干预措施
1
Erythropoietin(EPO)-naive BIW
干预措施: Dynepo (Epoetin delta) (Drug)
2
EPO-naive QW
干预措施: Dynepo (Drug)
3
EPO QW
干预措施: Dynepo (Drug)
4
EPO Q2W
干预措施: Dynepo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
时间窗: Baseline and 24 weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
次要结局
- Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL(week 16 and 24)
- Change From Baseline in Hematocrits at 16 and 24 Weeks(Baseline and Weeks 16 and 24)