A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluation the Efficacy and Safety of Intravenous CKD-11101 Versus Darbepoetin Alfa in Patients Who Had Renal Anemia Receiving Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 403
- 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 intravenous CKD-11101 versus Darbepoetin alfa in patients who have renal anemia receiving hemodialysis.
详细描述
This study was designed as randomized, double-blind, multi-center, Phase 3 clinical study to evaluate the efficacy and safety of intravenous CKD-11101 versus Darbepoetin alfa in patients who had renal anemia receiving hemodialysis.
The selection criteria are evaluated for 19-year-old patients who receive stable hemodialysis treatment for 3 months or more in patients with chronic renal failure. After completion of the stabilization period of 12 to 16 weeks for Darbepoetin Alfa, the subjects with the mean Hb levels of 10 to 12g/dl measured during the baseline visit and 0 week visit are randomized to the test and control groups in a 1:1 ratio during the randomization visit. They have a 20-week maintenance period and a 4-week evaluation period.
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
- •Inclusion Criteria
- •Patients with 19 years of age or older
- •Patients with anemia in chronic renal failure
- •Patients who started hemodialysis more than 3 months ago and receive appropriate hemodialysis, satisfying the following criterion:
- •Kt/V is ≥ 1.2 or Urea reduction ratio is ≥ 65%
- •Patients with the mean Hb levels of 10 to 12g/dl measured at the baseline and randomization visits
- •Patients with enough body iron stores who meet the following item:
- •Serum ferritin ≥ 100ng/ml or Transferrin saturation ≥ 20%
- •Patients who have provided written consent to participate in the trial voluntarily
排除标准
- •Patients with uncontrolled hypertension
- •Patients who had hypersensitivity to erythropoietin agents
- •Patients who had known hypersensitivity to mammalian cell-derived products or diluting agents
- •Patients with history of severe cardiovascular diseases
- •Patients who have received red blood cell transfusion or hormone therapy for anemia correction within 12 weeks prior to randomization
- •Patients whose anemia is not caused by chronic renal failure or may affect anemia correction
- •Patients whose AST/ALT test results performed at screening exceed twice of normal upper limit
- •Patients who had experience of positive result in anti-erythropoietin antibody in previous treatment with erythropoiesis stimulating agent
- •Patients who have been planned to change the dialysis method
研究组 & 干预措施
NESP
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 (Biological)
CKD-11101
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 (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 level measured in Weeks 20 - 24] - [Mean of hemoglobin level measured at Weeks -4 - 0])
The equivalence test on mean hemoglobin level of test drug and to Reference Drug administration groups in evaluation period (Weeks 20 - 24) compared to the baseline (Weeks -4 - 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 to Reference Drug administration groups in evaluation period (Weeks 20 - 24) will be conducted.
次要结局
- Ratio of subjects who receive transfusion during maintenance period and evaluation period(Weeks 0 - 24)
- Ratio of subjects who changed dose during maintenance period and evaluation period(Weeks 0 - 24)
- Number of red blood cell transfusion per subject during maintenance period and evaluation period(Weeks 0 - 24)
- Ratio of subjects who achieve target level of hemoglobin during the evaluation period(Weeks 20 - 24)
- Mean hemoglobin levels at Weeks 20 and 24(Weeks 20, 24)
- Ratio of subjects who maintain hemoglobin level ≥ 10g/dl during maintenance period and evaluation period (interval of every 2 weeks)(Weeks 0 - 24)