Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) and Single-Blind Placebo-Controlled, Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Brief Summary: The primary objective of this study is to evaluate the efficacy and safety of roxadustat in participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy, previously treated with intravenous (IV) epoetin alfa.


Options:
A: Hemoglobin level (24 weeks)
B: Modeled Hgb Change From Baseline Over 4 Weeks of Treatment (Baseline (average of Week -2, -1 and Day 1) and Week 4)
C: Mean area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Area under concentration-time curve from time 0 to infinity (AUCinf) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Maximum observed concentration (Cmax) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Time to maximum observed concentration (Tmax) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Terminal half-life (t½) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Apparent clearance (CL/F) or clearance (CL) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Apparent volume of distribution (Vd/F) or volume of distribution (Vd) (Vadadustat: Days 1, 2, 8, and 10 (or End of Treatment). Erythropoiesis-stimulating agent: Days 1 and 2); Tmax for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); AUClast for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); AUCinf for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); Cmax for vadadustat metabolite(s) (Day 1: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose and prior to dosing. Day 8: predose; 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 10 or End of Treatment: predose); Serum erythropoietin concentration for the erythropoiesis-stimulating agent treatment group (Day 1: predose; 0.25, 1, 2, 3, 4, 5, 8, and 11 hours post dose. Day 2: 24 hours (-2 hours) post Day 1 dose)
D: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only (Week 7); Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks (Week 7); Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks (Weeks 17, 18, 19, and 20)

Answer: D