Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis
Brief Summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Arm Label: Group 1 (Early Epoetin Beta); Type: EXPERIMENTAL; Interventions: Drug: Epoetin beta | Arm Label: Group 2 (No/Late Epoetin Beta); Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin beta | Intervention Type: DRUG; Name: Epoetin beta; Assigned to Arm(s): Group 1 (Early Epoetin Beta), Group 2 (No/Late Epoetin Beta)
B: 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)
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: Active; Type: ACTIVE_COMPARATOR; Interventions: Drug: darbepoetin alfa | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: darbepoetin alfa; Assigned to Arm(s): Active

Answer: C