Table 1.
Pooled sample demographics and baseline characteristics.
| Parameter | Roxadustat N = 215 |
ESA N = 207 |
p Value |
|---|---|---|---|
| Sex (male), n (%) | 118 (54.9) | 108 (52.2) | 0.5769 a |
| Age b (y), mean (SD) | 51.0 (15.1) | 52.7 (15.0) | 0.2091 c |
| Race, n (%) | 0.0342 a | ||
| White | 147 (68.4) | 110 (53.1) | |
| Black or African American | 20 (9.3) | 29 (14.0) | |
| Asian | 29 (13.5) | 41 (19.8) | |
| American Indian or Alaska Native | 11 (5.1) | 17 (8.2) | |
| Native Hawaiian or other Pacific Islander | 0 | 0 | |
| Other | 8 (3.7) | 10 (4.8) | |
| Body weight (kg), mean (SD) | 75.1 (19.4) | 74.8 (19.4) | 0.9284 c |
| CKD etiology, n (%) d | 0.7159 a | ||
| Diabetic nephropathy | 64 (29.8) | 70 (33.8) | |
| Hypertensive nephropathy | 51 (23.7) | 51 (24.6) | |
| Other | 116 (54.0) | 104 (50.2) | |
| Cardiac, cerebrovascular, or TE disease, n (%) | 73 (34.0) | 71 (34.3) | 0.9403 a |
| Baseline Hb (g/dL), mean (SD) | 9.8 (1.2) | 9.7 (1.2) | 0.2531 c |
| Iron replete (TSAT ≥ 20% and ferritin ≥ 100 ng/mL) at baseline, n (%) | 187 (87.0) | 189 (91.3) | 0.1539 a |
| Baseline hsCRP (mg/L), mean (SD) | 12.1 (23.6) | 10.7 (36.3) | 0.1500 c |
| Baseline hsCRP, n (%) | 0.3932 a | ||
| ≤ULN | 107 (49.8) | 109 (52.7) | |
| >ULN | 79 (36.7) | 67 (32.4) | |
| Missing | 29 (13.5) | 31 (15.0) | |
| Baseline LDL-C (mg/dL), mean (SD) | 114.6 (47.4) | 108.6 (47.9) | 0.1462 c |
| Baseline serum hepcidin (µg/L), mean (SD) | 192.7 (152.3) | 238.6 (163.6) | 0.0039 c |
| Baseline serum iron (µmol/L), mean (SD) | 13.6 (6.3) | 14.1 (7.1) | 0.4425 c |
| Baseline ferritin (ng/mL), mean (SD) | 490.6 (413.8) | 529.8 (391.0) | 0.1500 c |
| Dialysis vintage e, n (%) | 0.3684 a | ||
| ≤4 months | 79 (36.7) | 93 (44.9) | |
| >4 months | 136 (63.3) | 114 (55.1) |
CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, hemoglobin; hsCRP, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein cholesterol; SD, standard deviation; TE, thromboembolic; TSAT, transferrin saturation; ULN, upper limit of normal. a p value determined by chi-squared test. b Age at completion of the informed consent or first dose date. c p value determined by Wilcoxon rank-sum test as data were not normally distributed. d Subjects may have more than one CKD etiology. e Relative to randomization. The category ≤ 4 months includes all participants in the HIMALAYAS study and patients in the PYRENEES, SIERRAS, and ROCKES studies that meet the criterion.