Table 3. Analysis of blood parameters after the first iron isomaltoside treatment.
| CKD stage 2 – 3 | CKD stage 4 | CKD stage 5 | Total | |
|---|---|---|---|---|
| Hb (g/dL) | ||||
| Anemic patients at baseline (WHO criteria)a | n = 16 | n = 36 | n = 38 | n = 90 |
| Change from baseline to post-treatment | 1.4 (0.8) | 0.7 (1.3) | 0.8 (1.4) | 0.9 (1.3) |
| p-valueb | < 0.0001 | 0.0021 | 0.0005 | < 0.0001 |
| Time of evaluation (weeks)c | 6.6 (4.1) | 9.2 (5.6) | 9.7 (11.3) | 8.9 (8.4) |
| Post-treatment level | 11.9 (1.1) | 11.2 (1.4) | 11.1 (1.4) | 11.3 (1.4) |
| Patients with Hb < 10 g/dL at baseline | n = 3 | n = 10 | n = 15 | n = 28 |
| Change from baseline to post-treatment | 1.5 (0.7) | 1.1 (1.4) | 1.3 (1.7) | 1.3 (1.5) |
| p-valueb | NS | NS | 0.0054 | 0.0001 |
| Time of evaluation (weeks)c | 7.9 (8.7) | 5.9 (3.7) | 6.3 (4.2) | 6.3 (4.4) |
| Post-treatment level | 10.3 (0.6) | 10.4 (1.4) | 10.6 (1.6) | 10.5 (1.4) |
| Ferritin (µg/L) | ||||
| Change from baseline to post-treatment | n = 8 | n = 25 | n = 21 | n = 54 |
| Mean (SD) | 114.0 (150.7) | 95.9 (175.9) | 111.6 (121.6) | 104.7 (150.5) |
| Median (IQR)d | 90.0 (18 – 113) | 77.0 (46 – 117) | 82.0 (43 – 184) | 86.0 (38 – 136) |
| p-valueb | 0.0114 | 0.0056 | 0.0011 | < 0.0001 |
| Time of evaluation (weeks)c | 11.6 (18.2) | 11.3 (6.4) | 10.5 (12.2) | 11.0 (10.9) |
| Post-treatment level | ||||
| Mean (SD) | 173.4 (213.2) | 219.5 (210.1) | 242.0 (162.8) | 221.4 (191.1) |
| Median (IQR)d | 138.0 (37.5 – 173.0) | 169.0 (120.0 – 218.0) | 200.0 (161.0 – 280.0) | 171.0 (120.0 – 238.0) |
| TSAT (%) | n = 6 | n = 17 | n = 10 | n = 33 |
| Change from baseline to post-treatment | 8.7 (7.3) | 12.8 (8.7) | 10.5 (10.5) | 11.4 (8.9) |
| p-valueb | 0.0242 | < 0.0001 | 0.0148 | < 0.0001 |
| Time of evaluation (weeks)c | 12.8 (21.3) | 13.1 (6.5) | 13.6 (16.9) | 13.2 (13.1) |
| Post-treatment level | 21.7 (5.6) | 30.7 (10.1) | 28.6 (9.6) | 28.4 (9.6) |
Data presented are means (SD) unless otherwise stated. aHb < 13 g/dL for men and Hb < 12 g/dL for women. bp-values reflect the two-tailed probability of comparing the mean change to null. cNumber of weeks post-treatment between the last administration of the first iron isomaltoside treatment and the follow-up blood test. dData not normally distributed are presented as median values. CKD = chronic kidney disease; Hb = hemoglobin; IQR = interquartile range; n = number of patients; NS = not significant; SD = standard deviation; TSAT = transferrin saturation; WHO = World Health Organization.