A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of Subcutaneous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Not on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 248
- 主要终点
- Changed amount of mean hemoglobin level in evaluation period compared to the baseline
研究概览
简要总结
The aim of this study was to compare and evaluate efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia not on dialysis.
详细描述
This was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of subcutaneous CKD-11101 versus Darbepoetin Alfa in patients who had stage 3, stage 4, and stage 5 chronic renal failure not on hemodialysis or peritoneal dialysis.
The selection criteria will be evaluated in patients who are receiving anemia correction among patients with 19 years of age or older and who had anemia in chronic renal failure of stage 3 or above.
Subjects who are identified to meet all inclusion criteria will be randomized to test group and control group at 1:1 ratio and go through 24-week correction period and efficacy evaluation period. During correction period and efficacy evaluation period, subjects will visit the clinical study center every 2 weeks to receive processes designated for each visit and be administered investigational product from the investigator in charge of drug administration.
In the safety evaluation period, all subjects will be administered test drug for 28weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NESP(Darbepoetin alfa)
The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.
干预措施: NESP(Darbepoetin alfa) (Biological)
CKD-11101(Darbepoetin alfa)
The dose of investigational product (Darbepoetin alfa) is adjusted according to the principles reflecting the MFDS (Ministry of Food and Drug Safety) approval for NESP, but is determined by the investigator's judgment considering various factors of the subjects that may affect the treatment of anemia.
干预措施: CKD-11101(Darbepoetin alfa) (Biological)
结局指标
主要结局
Changed amount of mean hemoglobin level in evaluation period compared to the baseline
时间窗: ([Mean of hemoglobin measured in Weeks 20 - 24] - [Hemoglobin measured at Week 0])
The equivalence test on mean hemoglobin level of test drug and reference drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Week 0) will be conducted.
Mean administration dose in evaluation period: Mean dose administered in Weeks 20 - 24
时间窗: Weeks 20 - 24
The equivalence test on mean administration dose of test drug and reference drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.
次要结局
- Days taken to reach target level of hemoglobin(Days taken to reach up to 24 weeks)
- Mean hemoglobin level for each week(Weeks 4, 8, 12, 16, 20, 24, and 52)
- Ratio of subjects who achieve target level of hemoglobin(Weeks 20 - 24)
- Changed amount of mean hemoglobin level at Weeks 20, 24, and 52 compared to the baseline(Weeks 20, 24, and 52)
- Ratio of subjects who receive transfusion(Weeks 0 - 24)