A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 75
- 主要终点
- To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI
研究概览
简要总结
Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Greater than or equal to 18 years of age
- •CRI with a creatinine clearance of less than 40 mL/min
- •Hemoglobin less than 11.0 g/dL
- •Serum vitamin B12 and folate levels above the lower limit of normal and iron replete
排除标准
- •Received rHuEPO therapy in the last 12 weeks
- •Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
- •Uncontrolled hypertension
- •Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding
研究组 & 干预措施
darbepoetin alfa
darbepoetin alfa (NESP)
干预措施: darbepoetin alfa (Drug)
结局指标
主要结局
To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI
时间窗: entire study - 24 weeks
次要结局
- To assess the safety and tolerability of chronic NESP therapy(entire study - 24 weeks)