Table 1.
Baseline and demographic characteristics (FAS).
| Characteristics | Pegmolesatide (N = 246) | Epoetin alfa (N = 124) |
|---|---|---|
| Age–yr | 49.0 (10.2)a | 49.5 (11.4)a |
| Distribution–no. (%) | ||
| <65 yr | 233 (94.7) | 111 (89.5) |
| ≥65 yr | 13 (5.3) | 13 (10.5) |
| Male sex–no. (%) | 153 (62.2) | 78 (62.9) |
| Dialysis methods–no. (%) | ||
| Hemodialysis | 166 (67.5) | 84 (67.7) |
| Peritoneal dialysis | 80 (32.5) | 40 (32.3) |
| Duration of stage 5 CKD–mo. | 58.9 (51.9)a | 61.6 (56.5)a |
| Transferrin saturation–%, median (Q1, Q3) | 33.0 (26.5, 42.1) | 32.6 (26.2, 40.8) |
| Ferritin–μg/L | 405 (403)a | 367 (326)a |
| Baseline hemoglobin level | ||
| Mean value—g/dL | 11.1 (0.8)a | 11.1 (0.7)a |
| Distribution–no. (%) | ||
| <11.4 g/dL | 166 (67.5) | 82 (66.1) |
| ≥11.5 g/dL | 80 (32.5) | 42 (33.9) |
| NYHA class–no. (%) | ||
| Class 0–I | 192 (78.0) | 106 (85.5) |
| Class II | 53 (21.5) | 18 (14.5) |
| History of cardiovascular risk factors–no. (%) | ||
| Hypertension | 239 (97.2) | 119 (96.0) |
| Diabetes | 45 (18.3) | 24 (19.4) |
| Hyperlipidemia | 91 (37.0) | 46 (37.1) |
| Coronary heart disease | 34 (13.8) | 19 (15.3) |
| Cerebrovascular disease | 42 (17.1) | 15 (12.1) |
| Heart failure | 43 (17.5) | 14 (11.3) |
| Arrhythmia | 15 (6.1) | 15 (12.1) |
| Peripheral vascular disease | 27 (11.0) | 15 (12.1) |
| Thromboembolic disease | 8 (3.3) | 1 (0.8) |
| History of allergy — no. (%) | 6 (2.4) | 6 (4.8) |
The full analysis set (FAS) comprised all patients who underwent randomization and received at least one dose of the study drug.
a
Mean (SD).