An Open-label, Randomized, Non-inferiority Study of Novel Erythropoiesis Stimulating Protein (NESP) and Recombinant Human Erythropoietin (rHuEPO) for the Treatment of Anemia in Pediatric Subjects With Chronic Renal Insufficiency (CRI) or End-stage Renal Disease (ESRD) Receiving Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 120
- 主要终点
- To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
研究概览
简要总结
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period. During the study, procedures include bloodwork for laboratory assessments and vital signs. Dose titration determined by hemoglobin values taken weekly during the study. Antibody samples taken at baseline and during the end of study assessments. A physical examination and laboratory tests will conclude the study.
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
- 接受健康志愿者
- 否
入选标准
- •1 to 18 years of age
- •ESRD receiving dialysis or CRI with eGFR less than 30 mL/min
- •Baseline hemoglobin 9.5 - 12.5 g/dL and iron replete
- •Stable rHuEPO therapy for 8 weeks
排除标准
- •Scheduled for a living-related kidney transplant
- •Uncontrolled blood pressure
- •seizure activity
- •Hyperparathyroidism
- •Major surgery within 12 weeks or active inflammatory disease
- •Currently receiving antibiotics
- •Clinical evidence of malignancy
- •Pregnant or breast-feeding
研究组 & 干预措施
rHuEPO
干预措施: rHuEPO (Drug)
darbepoetin alfa
干预措施: darbepoetin alfa (Drug)
结局指标
主要结局
To demonstrate that NESP is comparable (not inferior) to rHuEPO for the treatment of anemia in pediatric subjects with CRI or ESRD receiving dialysis
时间窗: Entire Study
次要结局
- To determine the safety and tolerability of NESP in the treatment of anemia in the pediatric population with CRI or ESRD(Entire Study)
