Table 1 Demographic and baseline characteristics of pooled treatment groups (total study population - safety population)a
Ferumoxytol Treatment Group (n = 486) | Iron Sucrose Treatment Group (n = 281) | Total (N = 767) | |
|---|---|---|---|
Mean age, years (SD) | 50.1 (15.75) | 52.8 (16.06) | 51.1 (15.90) |
Mean weight, kg (SD) | 70.9 (16.07) | 76.0 (20.29) | 72.8 (17.89) |
Mean height, cm (SD) | 165.8 (8.17) | 166.5 (8.18) | 166.0 (8.18) |
Sex, n (%) | |||
Female | 383 (78.8) | 199 (70.8) | 582 (75.9) |
Male | 103 (21.2) | 82 (29.2) | 185 (24.1) |
Race, n (%) | |||
American Indian/Alaskan Native | 0 (0.0) | 1 (0.4) | 1 (0.1) |
Asian | 51 (10.5) | 18 (6.4) | 69 (9.0) |
Black/African American | 27 (5.6) | 16 (5.7) | 43 (5.6) |
Native Hawaiian/other Pacific Islander | 2 (0.4) | 1 (0.4) | 3 (0.4) |
White | 390 (80.2) | 234 (83.3) | 624 (81.4) |
Other/multiracial | 16 (3.3) | 11 (3.9) | 27 (3.5) |
Ethnicity, n (%) | |||
Hispanic/Latino | 12 (2.5) | 13 (4.6) | 25 (3.3) |
Not Hispanic/Latino | 474 (97.5) | 268 (95.4) | 742 (96.7) |
CKD stage, n (%) | |||
Stage 1 (eGFR ≥90 mL/min) | 280 (57.6) | 126 (44.8) | 406 (52.9) |
Stage 2 (eGFR 60 to <90 mL/min) | 104 (21.4) | 59 (21.0) | 163 (21.3) |
Stage 3 (eGFR 30 to <60 mL/min) | 41 (8.4) | 33 (11.7) | 74 (9.6) |
Stage 4 (eGFR 15 to <30 mL/min) | 23 (4.7) | 20 (7.1) | 43 (5.6) |
Stage 5 (eGFR <15 mL/min) | 38 (7.8) | 42 (14.9) | 80 (10.4) |
Unknown | 0 (0.0) | 1 (0.4) | 1 (0.1) |
Dialysis status, n | |||
Hemodialysis | 34 | 36 | 70 |
ESA use, n (%) | 45 (9.3) | 40 (14.2) | 85 (11.1) |