Randomized, Double-blind, Parallel, Active Controlled Study to Compare Pharmacokinetic/Pharmacodynamic Parameters of Nanogen's Darbepoetin Alfa With Aranesp® (Amgen) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- PK parameters comparison between NNG-DEPO and Aranesp®: Cmax
研究概览
简要总结
This is a double-blind, randomized, active-control study with 2-study arms-darbepoetin alfa biosimilar and Aranesp, noninferiority trial design in dialysis patients. Dialysis patients will be randomized into 1:1 ratio to receive either Darbepoetin alfa or Aranesp 0.75 µg/kg by subcutaneous injection every other week for 24 weeks.
Pharmacokinetic/pharmacodynamic parameters for evaluation are assessed as per study endpoints at defined time points on all patients.
During the treatment, dose adjustments will be made as necessary to achieve a hemoglobin response, defined as maintaining Hb in target range 10 - 12 g/dL.
详细描述
PHASE OF TRIAL: I SAMPLE SIZE: 43 for pharmacokinetic/pharmacodynamic parameters TARGET POPULATION: Patients with chronic kidney disease undergoing dialysis
STUDY GROUPS:
- Darbepoetin alfa (Nanogen) SC 0.75 µg/kg Q2W, for 24 weeks.
- Aranesp® (Amgen) SC 0.75 µg/kg Q2W, for 24 weeks.
PK ASSESSMENT: Blood samples for PK assessments will be collected at:
- IV: time zero (predose) before injection of study drug and then after 0.25, 0.5, 4, 12, 24, 48, 96, 144, 240 and 336 hours post-dose.
- SC: time zero (predose) before injection of study drug and then after 4, 12, 24, 48, 96, 144, 240 and 336 hours post-dose.
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 65 Years（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
Stimus
Treatment: Nanogen's Darbepoetin alfa 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe
干预措施: Stimus (Biological)
Aranesp
Control: Amgen's Aranesp® 10µg/0.4mL, 20µg/0.5mL, 40µg/0.4mL, 60µg/0.3mL, prefilled syringe
干预措施: Stimus (Biological)
结局指标
主要结局
PK parameters comparison between NNG-DEPO and Aranesp®: Cmax
时间窗: IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose
Serum peak concentrations (Cmax)
PK parameters comparison between NNG-DEPO and Aranesp®: AUC(0, t)
时间窗: IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose
Area under the curve from 0 to t (AUC 0-t)
次要结局
- PK parameters comparison between NNG-DEPO and Aranesp®: AUC(0,∞)(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)
- PK parameters comparison between NNG-DEPO and Aranesp®: λz.(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)
- Proportion of the adverse events (AE) including physical examinations, vital signs, and clinical laboratory investigations.(Week 0 (Assessed predose)- Week 24])
- PD parameters comparison between NNG-DEPO and Aranesp®: Cmax of reticulocytes(Assessed predose and at and at 24;48;96;144;240;336 hours postdose)
- PD parameters comparison between NNG-DEPO and Aranesp®: Tmax of reticulocytes(Assessed predose and at and at 24;48;96;144;240;336 hours postdose)
- PD parameters comparison between NNG-DEPO and Aranesp®: AUC(0, t) of reticulocytes(Assessed predose and at and at 24;48;96;144;240;336 hours postdose)
- PK parameters comparison between NNG-DEPO and Aranesp®:Tmax(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)
- PK parameters comparison between NNG-DEPO and Aranesp®:Vz/F(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)
- PK parameters comparison between NNG-DEPO and Aranesp®:T1/2(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)
- PK parameters comparison between NNG-DEPO and Aranesp®: CL/F(IV:Assessed predose and at 0.25; 0.5; 4;12;24;48;96;144;240;336 hours postdose/ SC: Assessed predose and at 4;12;24;48;96;144;240;336 hours postdose)