A Multi-Center, Double-Blind, Randomized Study Evaluating De Novo Weekly and Once Every Two Week Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
研究概览
简要总结
The primary objectives of this study are the following:
- To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and
- To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis
- •Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL
- •Transferrin saturation (Tsat) greater than or equal to 20%
排除标准
- •Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
- •other hematologic disorders
- •upper or lower gastrointenstinal bleeding within 6 months prior to randomization
- •uncontrolled hypertension
- •prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack
- •prior history (within 6 months prior to randomization) of thromboembolism
研究组 & 干预措施
Darbepoetin Alfa QW
Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
干预措施: Darbepoetin Alfa (Drug)
Darbepoetin Alfa Q2W
Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
干预措施: Darbepoetin Alfa (Drug)
Darbepoetin Alfa Q2W
Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
时间窗: 24 weeks
The proportion of participants achieving hemoglobin ≥ 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin ≥ 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set.
次要结局
- Hemoglobin Concentration Over Time(Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.)
- Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL(24 weeks)
- Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores(Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25))
- Change From Baseline in Diastolic Blood Pressure Over Time(Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.)
- Darbepoetin Alfa Weight-Adjusted Dose Over Time(Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.)
- Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study(25 weeks)
- Maximum Increase in Hemoglobin Over Any 2 Week Period(25 weeks)
- Number of Participants Who Developed Anti-erythropoiesis Antibodies(25 weeks)
- Time to First Hemoglobin Value ≥ 10.0 g/dL(24 weeks)
- Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores(Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25))
- Number of Participants With Treatment-emergent Adverse Events(25 weeks)
- Hemoglobin Serial Rate of Change (ROC) Over Time(Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.)
- Change From Baseline in Systolic Blood Pressure Over Time(Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.)
- Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age(Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose)