临床试验/NCT00093977

NCT00093977已完成3 期

An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease

Amgen0 个研究点目标入组 1,100 人开始时间: 2004年10月最近更新: 2013年5月24日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Amgen
入组人数: 1,100
主要终点: To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

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

•Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
•Currently on erythropoietic therapy
•Controlled hypertension
•Clinically stable

排除标准

未提供

研究组 & 干预措施

darbepoetin alfa SF

Experimental

干预措施: darbepoetin alfa SF (Drug)

结局指标

主要结局

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile

时间窗: Entire Study

次要结局

To characterize laboratory parameters in subjects with CKD(Entire Study)

研究者

发起方

Amgen

申办方类型

Industry

责任方

Sponsor

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