Table 1.
Patient demographics and baselinea characteristics (safety population)
| DIALOGUE 3 | Molidustat (n = 118) | Darbepoetin (n = 42) | Total (n = 160) |
|---|---|---|---|
| Age, yearsb | |||
| Mean (SD) | 70 (10) | 69 (12) | 69 (11) |
| Min, max | 35, 89 | 34, 94 | 34, 94 |
| Gender, n (%) | |||
| Male | 57 (48) | 22 (52) | 79 (49) |
| Female | 61 (52) | 20 (48) | 81 (51) |
| Race, n (%) | |||
| White | 73 (62) | 32 (76) | 105 (66) |
| Black | 0 | 1 (2) | 1 (0.6) |
| Asian | 45 (38) | 9 (21) | 54 (34) |
| Parent study, n (%) | |||
| DIALOGUE 1 | 66 (56) | 17 (40) | 83 (52) |
| DIALOGUE 2 | 52 (44) | 25 (60) | 77 (48) |
| eGFR, mL/min/1.73 m2 at baselinec | |||
| n | 111 | 42 | 153 |
| Mean (SD) | 23 (14) | 22 (13) | 23 (15) |
| Min, max | 5, 67 | 7, 54 | 5, 67 |
| eGFR category at baseline, n (%)c | |||
| <15 mL/min/1.73 m2, stage 5 | 42 (36) | 16 (38) | 58 (36) |
| 15 to <30 mL/min/1.73 m2, stage 4 | 37 (31) | 17 (40) | 54 (34) |
| 30 to <60 mL/min/1.73 m2, stage 3 | 30 (25) | 9 (21) | 39 (24) |
| Missing | 9 (8) | 0 | 9 (6) |
| Etiology of CKD (reported for ≥5% of patients in any group), n (%)d | |||
| Hypertension | 48 (41) | 15 (36) | 63 (39) |
| Diabetes mellitus | 43 (36) | 16 (38) | 59 (37) |
| Autoimmune disease | 9 (8) | 5 (12) | 14 (9) |
| Infection | 9 (8) | 3 (7) | 12 (8) |
| Polycystic kidney disease | 5 (4) | 3 (7) | 8 (5) |
| CRP | |||
| Mean (SD), mg/L | 5.1 (10.2) | 10.8 (21.6) | 6.7 (14.4) |
| DIALOGUE 5 | Molidustat (n = 57) | Epoetin (n = 30) | Total (n = 87) |
|---|---|---|---|
| Age, yearsb | |||
| Mean (SD) | 61 (12) | 59 (9) | 60 (11) |
| Min, max | 25, 82 | 39, 74 | 25, 82 |
| Gender, n (%) | |||
| Male | 33 (58) | 23 (77) | 56 (64) |
| Female | 24 (42) | 7 (23) | 31 (36) |
| Race, n (%) | |||
| White | 28 (49) | 14 (47) | 42 (48) |
| Black | 16 (28) | 10 (33) | 26 (30) |
| Asian | 10 (18) | 6 (20) | 16 (18) |
| Others | 2 (4) | 0 | 2 (2) |
| Not reported | 1 (2) | 0 | 1 (1) |
| Dialysis frequency, n (%) | |||
| 3 times per week | 57 (100) | 30 (100) | 87 (100) |
| Etiology of CKD (reported for >5% of patients in any group),n (%)d | |||
| Diabetes mellitus | 30 (53) | 18 (60) | 48 (55) |
| Hypertension | 19 (33) | 12 (40) | 31 (36) |
| Others | 6 (11) | 0 | 6 (7) |
| Glomerulonephritis | 3 (5) | 2 (7) | 5 (6) |
| Polycystic kidney disease | 1 (2) | 0 | 1 (1) |
| CRP | |||
| Mean (SD), mg/L | 0.7 (1.2) | 0.6 (0.8) | 0.7 (1.1) |
a
Baseline measurement was defined as the measurement taken prior to the first study drug administration in the extension studies.
b
Age was defined as the baseline value of the parent studies.
c
eGFR was calculated using the Modification of Diet in Renal Disease formula.
d
One patient could have more than 1 etiology. CKD, chronic kidney disease; CRP, C-reactive protein; eGFR, estimated glomerular filtration rate; max, maximum; min, minimum.