Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 52-week, Phase III, Open-label, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease
Brief Summary: This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects (Erythropoiesis-Stimulating Agent \[ESA\] users and ESA non-users) randomized to receive GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort 2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week treatment phase (including primary efficacy evaluation period \[Weeks 40 to 52\]), and a 4-week follow-up phase following the treatment phase. The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort 1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.


Options:
A: Arm Label: Cohort A-1 (Roxadustat 1.0 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-2 (Roxadustat 1.5 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-3 (Roxadustat 2.0 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-4 (Roxadustat 1.8 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-5 (Roxadustat 1.8 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-6 (Roxadustat 1.3 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-9 (Roxadustat 2.0 mg/kg); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohorts A (Epoetin Alfa); Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin Alfa | Arm Label: Cohort B-1 (Roxadustat 1.5 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort B-2 (Roxadustat 2.0 mg/kg TIW); Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Cohort B (Epoetin Alfa); Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin Alfa | Arm Label: Cohort B (Placebo); Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Roxadustat; Assigned to Arm(s): Cohort A-1 (Roxadustat 1.0 mg/kg TIW), Cohort A-10 (Weight Tiered Roxadustat 70-120-200 mg), Cohort A-2 (Roxadustat 1.5 mg/kg TIW), Cohort A-3 (Roxadustat 2.0 mg/kg TIW), Cohort A-4 (Roxadustat 1.8 mg/kg TIW), Cohort A-5 (Roxadustat 1.8 mg/kg TIW), Cohort A-6 (Roxadustat 1.3 mg/kg TIW), Cohort A-7 (Weight Tiered Roxadustat 70-100-150 mg), Cohort A-8 (Weight Tiered Roxadustat 70-120-200 mg), Cohort A-9 (Roxadustat 2.0 mg/kg), Cohort B-1 (Roxadustat 1.5 mg/kg TIW), Cohort B-2 (Roxadustat 2.0 mg/kg TIW) | Intervention Type: DRUG; Name: Epoetin Alfa; Assigned to Arm(s): Cohort B (Epoetin Alfa), Cohorts A (Epoetin Alfa) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Cohort B (Placebo)
B: Arm Label: Vadadustat; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa
C: Arm Label: ASP1517 Low dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: ASP1517 Middle dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: ASP1517 High dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: Darbepoetin group; Type: ACTIVE_COMPARATOR; Interventions: Drug: darbepoetin alfa | Intervention Type: DRUG; Name: roxadustat; Assigned to Arm(s): ASP1517 High dose group, ASP1517 Low dose group, ASP1517 Middle dose group | Intervention Type: DRUG; Name: darbepoetin alfa; Assigned to Arm(s): Darbepoetin group
D: Arm Label: Daprodustat in ND participants; Type: EXPERIMENTAL; Interventions: Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tablet | Arm Label: Epoetin beta pegol in ND participants; Type: ACTIVE_COMPARATOR; Interventions: Drug: Epoetin beta pegol | Arm Label: Daprodustat in PD participants; Type: EXPERIMENTAL; Interventions: Drug: 1 to 4 mg tablets of GSK1278863, Drug: 6 mg GSK1278863 tablet | Intervention Type: DRUG; Name: 1 to 4 mg tablets of GSK1278863; Assigned to Arm(s): Daprodustat in ND participants, Daprodustat in PD participants | Intervention Type: DRUG; Name: 6 mg GSK1278863 tablet; Assigned to Arm(s): Daprodustat in ND participants, Daprodustat in PD participants | Intervention Type: DRUG; Name: Epoetin beta pegol; Assigned to Arm(s): Epoetin beta pegol in ND participants

Answer: D