Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Four-week, Phase IIa, Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Switching Subjects From a Stable Dose of Recombinant Human Erythropoietin to GSK1278863 in Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease
Brief Summary: This is a four-week, Phase IIa, randomized, active-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of switching subjects from stable rhEPO to GSK1278863 in approximately 68 hemodialysis-dependent subjects with anemia associated with chronic kidney disease. The study consists of a screening phase of 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 9.5-12.0 g/dL and the subjects must have received the same rhEPO product with total weekly doses that varied by no more than 50% during the 4 weeks prior to the Screening visit (Week -1. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response in hemodialysis-dependent (HDD) subjects with anemia associated with chronic kidney disease after switching from a stable maintenance dose of recombinant human erythropoetin (rhEPO).


Options:
A: Arm Label: FG-4592; Type: EXPERIMENTAL; Interventions: Drug: FG-4592 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: FG-4592; Assigned to Arm(s): FG-4592 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Part 1: ESA-Naïve Participants - Low Weight Based Dosing; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 1: ESA-Naïve Participants - Standard Weight Based Dosing; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 1: ESA-Treated Participants - Low Weight Based Dosing; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 1: ESA-Treated Participants - Standard Weight Based Dosing; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 2: Roxadustat QW; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 2: Roxadustat BIW; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Arm Label: Part 2: Roxadustat TIW; Type: EXPERIMENTAL; Interventions: Drug: Roxadustat | Intervention Type: DRUG; Name: Roxadustat; Assigned to Arm(s): Part 1: ESA-Naïve Participants - Low Weight Based Dosing, Part 1: ESA-Naïve Participants - Standard Weight Based Dosing, Part 1: ESA-Treated Participants - Low Weight Based Dosing, Part 1: ESA-Treated Participants - Standard Weight Based Dosing, Part 2: Roxadustat BIW, Part 2: Roxadustat QW, Part 2: Roxadustat TIW
C: Arm Label: ASP1517 Group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: Darbepoetin alfa Group; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: roxadustat; Assigned to Arm(s): ASP1517 Group | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa Group
D: Arm Label: 0.5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 2 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: rhEPO; Type: ACTIVE_COMPARATOR; Interventions: Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): 0.5 mg GSK1278863, 2 mg GSK1278863, 5 mg GSK1278863 | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): rhEPO

Answer: D