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临床试验/NCT00527137
NCT00527137已完成3 期

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

Amgen0 个研究点目标入组 120 人开始时间: 2000年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: rHuEPO (Drug)

darbepoetin alfa

Experimental

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)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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