Table 1.
Baseline characteristics of subjects who received ≥ 1 dose of the study drug (safety population)
| FCM (n = 147) | Oral iron (n = 103) | P-value | |
|---|---|---|---|
| Age (years) | 65.4 ± 12.6 | 66.8 ± 13.5 | 0.39a |
| Sex (% female) | 63.9 | 70.9 | 0.28b |
| Race (%) | 0.16b | ||
| Caucasian | 49.0 | 58.3 | |
| African American | 27.9 | 26.2 | |
| Hispanic | 15.6 | 9.7 | |
| Asian | 6.1 | 5.8 | |
| Other | 1.4 | 0.0 | |
| Weight (kg) | 84.6 ± 23.0 | 89.5 ± 27.2 | 0.12a |
| Height (cm) | 163.8 ± 11.7 | 164.3 ± 8.6 | 0.73a |
| CKD degree (%) | 0.67b | ||
| 30.1–45.0 mL/min/1.73 m2 | 32.7 | 32.0 | |
| 15.1–30.0 mL/min/1.73 m2 | 53.1 | 49.5 | |
| ≤ 15.0 mL/min/1.73 m2 | 14.3 | 18.4 | |
| Hb (g/dL) | 10.1 ± 0.74 | 10.0 ± 0.86 | 0.38a |
| Hb category (%) | 0.70b | ||
| Hb ≤ 9.0 g/dL | 10.2 | 13.6 | |
| Hb 9.1–10.0 g/dL | 26.5 | 26.2 | |
| Hb 10.1–11.0 g/dL | 63.3 | 60.2 | |
| Ferritin (ng/mL) | 111.8 ± 85.1 | 104.8 ± 75.1 | 0.50a |
| TSAT (%) | 15.4 ± 5.5 | 15.8 ± 5.6 | 0.59a |
| Previous iron therapy (%) | 44.2 | 56.3 | 0.07b |
| History of sensitivity to IV iron (%) | 2.0 | 1.9 | 1.00b |
| ESA use at baseline (%) | 23.8 | 25.2 | 0.88b |
Values are expressed as mean ± standard deviation or percentage.
CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; FCM, ferric carboxymaltose; Hb, haemoglobin; IV, intravenous; TSAT, transferrin saturation.
a
t-test.
b
Fisher’s exact test.