Table 2.
Summary of subjects who achieved the primary end point of an increase in Hb ≥ 1.0 g/dL anytime during the study by subgroup (mITT population)
| FCM n/N (%) | Oral iron n/N (%) | P-value | |
|---|---|---|---|
| Baseline Hb | |||
| Hb ≤ 9.0 g/dL | 9/14 (64.3) | 5/14 (35.7) | 0.257 |
| Hb 9.1–10.0 g/dL | 28/38 (73.7) | 14/27 (51.9) | 0.113 |
| Hb 10.1–11.0 g/dL | 50/92 (54.3) | 16/60 (26.7) | < 0.001 |
| CKD degree | |||
| 30.1–45.0 mL/min/1.73 m2 | 33/48 (68.8) | 5/18 (27.8) | 0.192 |
| 15.1–30.0 mL/min/1.73 m2 | 43/75 (57.3) | 18/51 (35.3) | 0.019 |
| ≤ 15.0 mL/min/1.73 m2 | 11/21 (52.4) | 5/18 (37.5) | 0.011 |
| Baseline ferritin | |||
| < 100 ng/mL | 56/78 (71.8) | 21/51 (41.2) | < 0.001 |
| ≥ 100 ng/mL | 31/66 (47.0) | 14/50 (28.0) | 0.054 |
| Baseline TSAT | |||
| < 15% | 47/61 (77.0) | 20/41 (48.8) | 0.005 |
| 15–< 20% | 24/50 (48.0) | 8/35 (22.9) | 0.024 |
| 20–25% | 16/33 (48.5) | 7/25 (28.0) | 0.175 |
| ESA use at baseline | |||
| No | 59/111 (53.2) | 23/77 (29.9) | 0.002 |
| Yes | 28/33 (84.8) | 12/24 (50.0) | 0.008 |
| Race | |||
| Caucasian | 47/71 (66.2) | 22/59 (37.3) | 0.001 |
| Non-Caucasian | 40/73 (54.8) | 13/42 (31.0) | 0.019 |
| Gender | |||
| Female | 54/91 (59.3) | 24/71 (33.8) | 0.002 |
| Male | 33/53 (62.3) | 11/30 (36.7) | 0.039 |
| Age | |||
| < 65 years | 45/64 (70.3) | 16/42 (38.1) | 0.001 |
| ≥ 65 years | 42/80 (52.5) | 19/59 (32.2) | 0.024 |
CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; FCM, ferric carboxymaltose; Hb, haemoglobin; mITT, modified intention-to-treat; n/N number of subjects with response/number of subjects in group; TSAT, transferrin saturation.