NCT00925587已完成3 期
A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis
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
- 358
- 试验地点
- 1
- 主要终点
- Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
研究概览
简要总结
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
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
- Double (Participant, Investigator)
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
- •≥ 18 years of age
- •Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)
- •Two consecutive screening Hb values taken at least 7 days apart must each be <10.0 g/dL
- •TSAT ≥ 15%
排除标准
- •Upper or lower GI bleeding within 6 months before enrolment
- •ESA use within 12 weeks before enrolment
- •Uncontrolled hypertension
- •Systemic haematologic disorders
- •Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.
- •Grand mal seizure within 6 months prior to enrolment
- •Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.
- •Red blood cell transfusion within 12 weeks prior to enrolment
- •Androgen therapy within 8 weeks prior to enrolment
- •Pregnancy or breast feeding, or inadequate contraception
- •Currently receiving immunosuppressive therapy
研究组 & 干预措施
Q2W
Active Comparator
Q2W administration of darbepoetin alfa.
干预措施: darbepoetin alfa (Drug)
QM
Active Comparator
QM administration of darbepoetin alfa
干预措施: darbepoetin alfa (Drug)
结局指标
主要结局
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
时间窗: Baseline Week 33
The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
次要结局
- Hb at Baseline(Baseline)
- Hb at Week 3(Week 3)
- Hb at Week 5(Week 5)
- Hb at Week 7(Week 7)
- Hb at Week 9(Week 9)
- Hb at Week 11(Week 11)
- Hb at Week 13(Week 13)
- Hb at Week 15(Week 15)
- Hb at Week 17(Week 17)
- Hb at Week 19(Week 19)
- Hb at Week 21(Week 21)
- Hb at Week 23(Week 23)
- Hb at Week 25(Week 25)
- Hb at Week 27(Week 27)
- Hb at Week 29(Week 29)
- Hb at Week 31(Week 31)
- Hb at Week 33(Week 33)
- Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.(Baseline to Week 33)
- Darbepoetin Alfa Dose at Week 1(Week 1)
- Darbepoetin Alfa Dose at Week 3(Week 3)
- Darbepoetin Alfa Dose at Week 5(Week 5)
- Darbepoetin Alfa Dose at Week 7(Week 7)
- Darbepoetin Alfa Dose at Week 9(Week 9)
- Darbepoetin Alfa Dose at Week 11(Week 11)
- Darbepoetin Alfa Dose at Week 13(Week 13)
- Darbepoetin Alfa Dose at Week 15(Week 15)
- Darbepoetin Alfa Dose at Week 17(Week 17)
- Darbepoetin Alfa Dose at Week 19(Week 19)
- Darbepoetin Alfa Dose at Week 21(Week 21)
- Darbepoetin Alfa Dose at Week 23(Week 23)
- Darbepoetin Alfa Dose at Week 25(Week 25)
- Darbepoetin Alfa Dose at Week 27(Week 27)
- Darbepoetin Alfa Dose at Week 29(Week 29)
- Darbepoetin Alfa Dose at Week 31(Week 31)
- Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)(Weeks 29-33)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 3(Week 3)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 5(Week 5)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 7(Week 7)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 9(Week 9)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 11(Week 11)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 13(Week 13)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 15(Week 15)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 17(Week 17)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 19(Week 19)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 21(Week 21)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 23(Week 23)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 25(Week 25)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 27(Week 27)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 29(Week 29)
- Ratio of Darbepoetin Alfa Dose to Baseline at Week 31(Week 31)
- Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)(Weeks 1-33)
- Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)(Weeks 1-33)
- Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)(Evaluation Period)
研究者
研究点 (1)
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