Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
Brief Summary: This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.


Options:
A: Arm Label: Erythropoiesis Stimulating Agents; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin Alfa, Drug: Epoetin Alfa, Drug: Epoetin Beta, Drug: methoxy polyethylene glycol-epoetin beta | Arm Label: Methoxy Polyethylene Glycol-Epoetin Beta; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin Alfa, Drug: Epoetin Alfa, Drug: methoxy polyethylene glycol-epoetin beta | Intervention Type: DRUG; Name: Darbepoetin Alfa; Assigned to Arm(s): Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta | Intervention Type: DRUG; Name: Epoetin Alfa; Assigned to Arm(s): Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta | Intervention Type: DRUG; Name: Epoetin Beta; Assigned to Arm(s): Erythropoiesis Stimulating Agents | Intervention Type: DRUG; Name: methoxy polyethylene glycol-epoetin beta; Assigned to Arm(s): Erythropoiesis Stimulating Agents, Methoxy Polyethylene Glycol-Epoetin Beta
B: Arm Label: Epoetin Bio-Manguinhos; Type: EXPERIMENTAL; Interventions: Drug: Epoetin Alfa-BioManguinhos | Arm Label: EPO-BioSimilar; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin Alfa-BioSimilar | Intervention Type: DRUG; Name: Epoetin Alfa-BioManguinhos; Assigned to Arm(s): Epoetin Bio-Manguinhos | Intervention Type: DRUG; Name: Epoetin Alfa-BioSimilar; Assigned to Arm(s): EPO-BioSimilar
C: Arm Label: RO0503821 (1x/2 Weeks); Type: EXPERIMENTAL; Interventions: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] | Arm Label: Darbepoetin (1x/1-2 Weeks); Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin (1x/1-2 Weeks) | Intervention Type: DRUG; Name: methoxy polyethylene glycol-epoetin beta [Mircera]; Assigned to Arm(s): RO0503821 (1x/2 Weeks)
D: Arm Label: HX575 epoetin alfa; Type: EXPERIMENTAL; Interventions: Drug: HX575 epoetin alfa | Arm Label: US-licensed epoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: US-licensed epoetin alfa | Intervention Type: DRUG; Name: HX575 epoetin alfa; Assigned to Arm(s): HX575 epoetin alfa | Intervention Type: DRUG; Name: US-licensed epoetin alfa; Assigned to Arm(s): US-licensed epoetin alfa

Answer: A