Table 1.
Patient demographics and baseline characteristics in DIALOGUES 1, 2, and 4
| FAS |
Non-iron users |
||||||
|---|---|---|---|---|---|---|---|
| molidustat | control group | total | molidustat | control group | total | ||
| Dialogue 1 | n = 101 | n = 20 | n = 121 | n = 53 | n = 8 | n = 61 | |
| Age, years, mean (SD) | 68.7 (12.0) | 67.1 (15.9) | 68.4 (12.6) | 70.1 (11.4) | 78.6 (6.9) | 71.2 (11.3) | |
| Women, n (%) | 45 (44.6) | 11 (55.0) | 56 (46.3) | 25 (47.2) | 4 (50.0) | 29 (47.5) | |
| Race, n (%) | |||||||
| White | 63 (62.4) | 15 (75.0) | 78 (64.5) | 34 (64.2) | 6 (75.0) | 40 (65.6) | |
| Asian | 38 (37.6) | 5 (25.0) | 43 (35.5) | 19 (35.8) | 2 (25.0) | 21 (34.4) | |
| Black | 0 | 0 | 0 | 0 | 0 | 0 | |
| Other | 0 | 0 | 0 | 0 | 0 | 0 | |
| CKD duration, years, mean (SD) | 4.5 (4.5) | 3.5 (2.7) | 4.3 (4.3) | 4.5 (5.0) | 2.7 (2.3) | 4.3 (4.8) | |
| CKD etiologya, n (%) | |||||||
| Diabetes | 45 (44.6) | 9 (45.0) | 54 (44.6) | 23 (43.4) | 4 (50.0) | 27 (44.3) | |
| Hypertension | 45 (44.6) | 6 (30.0) | 51 (42.1) | 25 (47.2) | 3 (37.5) | 28 (45.9) | |
| Others | 28 (27.7) | 6 (30.0) | 34 (28.1) | 16 (30.2) | 1 (12.5) | 17 (16.4) | |
| eGFR, mL/min/1.73 m2, mean (SD) | 23.4 (12.3) | 23.0 (11.6) | 23.3 (12.1) | 25.2 (12.5) | 28.8 (13.0) | 25.7 (12.5) | |
| Hb level, g/dL, mean (SD) | 9.5 (0.7) | 9.5 (0.6) | 9.5 (0.7) | 9.4 (0.8) | 9.4 (0.7) | 9.4 (0.8) | |
| CRP, mg/L, mean (SD) | 7.2 (16.4) | 4.3 (5.1) | 6.7 (15.2) | 7.4 (20.7) | 3.3 (4.0) | 6.9 (19.4) | |
| Dialogue 2 | n = 92 | n = 32 | n = 124 | n = 42 | n = 16 | n = 58 | |
| Age, years, mean (SD) | 67.6 (10.5) | 68.8 (8.7) | 67.9 (10.0) | 67.4 (11.1) | 68.3 (8.3) | 67.6 (10.3) | |
| Women, n (%) | 47 (51.1) | 14 (43.8) | 61 (49.2) | 19 (45.2) | 6 (37.5) | 25 (43.1) | |
| Race, n (%) | |||||||
| White | 69 (75.0) | 25 (78.1) | 94 (75.8) | 33 (78.6) | 12 (75.0) | 45 (77.6) | |
| Asian | 22 (23.9) | 6 (18.8) | 28 (22.6) | 9 (21.4) | 3 (18.8) | 12 (20.7) | |
| Black | 1 (1.1) | 1 (3.1) | 2 (1.6) | 0 | 1 (6.3) | 1 (1.7) | |
| Other | 0 | 0 | 0 | 0 | 0 | 0 | |
| CKD duration, years, mean (SD) | 6.7 (6.4) | 5.8 (5.0) | 6.5 (6.1) | 7.2 (6.7) | 6.3 (5.8) | 6.9 (6.4) | |
| CKD etiologya, n (%) | |||||||
| Diabetes | 31 (33.7) | 10 (31.3) | 41 (33.1) | 14 (33.3) | 4 (25.0) | 18 (31.0) | |
| Hypertension | 31 (33.7) | 13 (40.6) | 44 (35.5) | 15 (35.7) | 8 (50.0) | 23 (39.7) | |
| Others | 43 (46.7) | 15 (46.9) | 58 (46.8) | 20 (47.6) | 8 (50.0) | 28 (48.3) | |
| eGFR, mL/min/1.73 m2, mean (SD) | 20.4 (11.4) | 21.9 (12.1) | 20.8 (11.5) | 19.0 (9.6) | 20.6 (12.3) | 19.5 (10.3 | |
| Hb level, g/dL, mean (SD) | 10.8 (0.7) | 10.9 (0.7) | 10.8 (0.7) | 10.8 (0.7) | 10.8 (0.9) | 10.8 (0.7) | |
| CRP, mg/L, mean (SD) | 7.4 (14.9) | 6.5 (11.2) | 7.2 (14.0) | 6.3 (12.8) | 8.8 (15.2) | 7.0 (13.5) | |
| Dialogue 4 | n = 157 | n = 42 | n = 199 | n = 59 | n = 15 | n = 74 | |
| Age, years, mean (SD) | 59.4 (12.5) | 58.9 (9.1) | 59.3 (11.8) | 60.8 (12.3) | 56.7 (10.1) | 60.0 (12.0) | |
| Women, n (%) | 66 (42.0) | 13 (31.0) | 79 (39.7) | 27 (45.8) | 5 (33.3) | 32 (43.2) | |
| Race, n (%) | |||||||
| White | 84 (53.5) | 18 (42.9) | 102 (51.3) | 29 (49.2) | 5 (33.3) | 34 (45.9) | |
| Asian | 29 (18.5) | 7 (16.7) | 36 (18.1) | 18 (30.5) | 3 (20.0) | 21 (28.4) | |
| Black | 40 (25.5) | 17 (40.5) | 57 (28.6) | 12 (20.3) | 7 (46.7) | 19 (25.7) | |
| Other | 4 (2.5) | 0 | 4 (2.0) | 0 | 0 | 0 | |
| CKD duration, years, mean (SD) | 6.4 (6.2) | 5.5 (4.3) | 6.2 (5.8) | 7.6 (6.8) | 5.6 (4.6) | 7.2 (6.4) | |
| Dialysis therapy duration, years, mean (SD) | 5.0 (5.2) | 5.3 (4.0) | 5.1 (5.0) | 5.6 (5.2) | 5.1 (3.9) | 5.5 (4.9) | |
| CKD etiologya, n (%) | |||||||
| Diabetes | 86 (54.8) | 24 (57.1) | 110 (55.3) | 26 (44.1) | 5 (33.3) | 31 (41.9) | |
| Hypertension | 48 (30.6) | 18 (42.9) | 66 (33.2) | 22 (37.3) | 7 (46.7) | 29 (39.2) | |
| Others | 31 (19.7) | 5 (11.9) | 36 (18.1) | 13 (22.0) | 3 (20.0) | 16 (21.6) | |
| Hb level, g/dL, mean (SD) | 10.5 (0.6) | 10.6 (0.5) | 10.5 (0.6) | 10.5 (0.6) | 10.6 (0.6) | 10.5 (0.6) | |
| CRP, mg/L, mean (SD) | 7.9 (13.5) | 7.1 (11.1) | 7.7 (13.0) | 5.4 (10.4) | 7.8 (10.8) | 5.9 (10.4) | |
a
One patient can have >1 etiology of CKD.
DIALOGUE, Dally orAL treatment increasing endOGenoUs Erythropoietin; FAS, full analysis set; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; Hb, hemoglobin; CRP, C-reactive protein.