Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients
Brief Summary: This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-week period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy along with safety between CinnaPoietin® and Eprex®.


Options:
A: Arm Label: Cohort A (0.4/150, 1x/ Week); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort B (0.4/150, 1x/ 3 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort C (0.4/150, 1x/ 4 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort D (0.8/150, 1x/ Week); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort E (0.8/150, 1x/ 3 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort F (0.8/150, 1x/ 4 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort G (1.2/150, 1x/ Week); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort H (1.2/150, 1x/ 3 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Cohort I (1.2/150, 1x/ 4 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Intervention Type: DRUG; Name: methoxy polyethylene glycol-epoetin beta [Mircera]; Assigned to Arm(s): Cohort A (0.4/150, 1x/ Week), Cohort B (0.4/150, 1x/ 3 Weeks), Cohort C (0.4/150, 1x/ 4 Weeks), Cohort D (0.8/150, 1x/ Week), Cohort E (0.8/150, 1x/ 3 Weeks), Cohort F (0.8/150, 1x/ 4 Weeks), Cohort G (1.2/150, 1x/ Week), Cohort H (1.2/150, 1x/ 3 Weeks), Cohort I (1.2/150, 1x/ 4 Weeks)
B: Arm Label: CinnaPoietin®; Type: EXPERIMENTAL; Interventions: Drug: CinnaPoietin®, Drug: Nephrovit, Drug: Vitamin B12 Injection | Arm Label: Eprex®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Eprex®, Drug: Nephrovit, Drug: Vitamin B12 Injection | Intervention Type: DRUG; Name: CinnaPoietin®; Assigned to Arm(s): CinnaPoietin® | Intervention Type: DRUG; Name: Eprex®; Assigned to Arm(s): Eprex® | Intervention Type: DRUG; Name: Nephrovit; Assigned to Arm(s): CinnaPoietin®, Eprex® | Intervention Type: DRUG; Name: Vitamin B12 Injection; Assigned to Arm(s): CinnaPoietin®, Eprex®
C: Arm Label: MIRCERA; Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Darbepoetin Alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin Alfa | Intervention Type: DRUG; Name: methoxy polyethylene glycol-epoetin beta [Mircera]; Assigned to Arm(s): MIRCERA
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: epoetin beta (NeoRecormon ®) | Arm Label: B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: epoetin beta (NeoRecormon ®); Assigned to Arm(s): A

Answer: B