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.~PD ASSESSMENT: Blood samples for PD assessments will be collected at time zero (predose) before injection of study drug and then after 24, 48, 96, 144, 240 and 336 hours post-dose.~SAFETY AND TOLERABILITY ASSESSMENT:~Safety and tolerability assessments will be performed at each visit. Following variables will be considered to define the safety and tolerability of investigational drugs:~Clinical adverse events (AEs): frequency of AEs, overall and by intensity.~Severe clinical adverse events (SAEs): frequency of AEs, overall and by intensity.~Symptoms directed physical examination including body weight, and vital signs during treatment period: mean change from baseline and the frequency of clinically relevant changes from baseline.~Laboratory tests: frequency of clinically relevant changes from baseline.~The frequency of any concomitant medication administered to treat any adverse events.~Presence of anti-bodies to darbepoetin alfa (immunogenicity).
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.