Table 4.
Time course of erythrocyte/iron-related parameters (mITT population) and phosphorus (safety analysis population)
| Parameters | FC-low | FC-high | SF |
|---|---|---|---|
| Hemoglobin, g/dL | |||
| Baseline | 9.25 ± 0.92 (n = 174) | 9.24 ± 0.89 (n = 172) | 9.24 ± 0.87 (n = 171) |
| Week 3 | 10.76 ± 0.84 (n = 173) | 11.32 ± 0.87 (n = 170) | 11.11 ± 0.82 (n = 167) |
| Week 7 | 11.99 ± 0.90 (n = 173) | 12.55 ± 0.95 (n = 168) | 12.35 ± 0.85 (n = 167) |
| RBC, 104/µL | |||
| Baseline | 416.5 ± 39.3 (n = 174) | 412.1 ± 34.3 (n = 172) | 409.7 ± 32.9 (n = 171) |
| Week 3 | 451.3 ± 39.8 (n = 173) | 454.9 ± 39.4 (n = 170) | 450.9 ± 39.0 (n = 167) |
| Week 7 | 460.8 ± 42.8 (n = 173) | 464.0 ± 38.1 (n = 168) | 460.2 ± 37.2 (n = 167) |
| Hct, % | |||
| Baseline | 29.54 ± 2.46 (n = 174) | 29.49 ± 2.42 (n = 172) | 29.39 ± 2.32 (n = 171) |
| Week 3 | 33.98 ± 2.33 (n = 173) | 35.49 ± 2.63 (n = 170) | 34.85 ± 2.36 (n = 167) |
| Week 7 | 37.00 ± 2.71 (n = 173) | 38.34 ± 2.73 (n = 168) | 37.85 ± 2.49 (n = 167) |
| MCV, fL | |||
| Baseline | 71.3 ± 6.3 (n = 174) | 71.8 ± 5.6 (n = 172) | 72.0 ± 5.8 (n = 171) |
| Week 3 | 75.6 ± 5.6 (n = 173) | 78.2 ± 4.3 (n = 170) | 77.6 ± 4.8 (n = 167) |
| Week 7 | 80.6 ± 5.3 (n = 173) | 82.8 ± 4.1 (n = 168) | 82.4 ± 4.2 (n = 167) |
| Retic, 104/µL | |||
| Baseline | 5.94 ± 2.03 (n = 174) | 5.62 ± 2.13 (n = 172) | 5.27 ± 1.91 (n = 171) |
| Week 3 | 9.14 ± 3.96 (n = 173) | 9.51 ± 3.51 (n = 170) | 8.97 ± 3.17 (n = 167) |
| Week 7 | 6.58 ± 2.72 (n = 173) | 6.12 ± 2.72 (n = 168) | 5.71 ± 2.48 (n = 167) |
| Iron, µg/dL | |||
| Baseline | 19.9 ± 20.7 (n = 174) | 17.9 ± 9.1 (n = 172) | 16.9 ± 7.4 (n = 171) |
| Week 3 | 41.3 ± 25.2 (n = 173) | 76.1 ± 51.4 (n = 169) | 51.8 ± 24.1 (n = 167) |
| Week 7 | 53.5 ± 31.4 (n = 173) | 79.1 ± 44.0 (n = 167) | 65.0 ± 40.9 (n = 167) |
| Ferritin, ng/mL | |||
| Baseline | 4.45 ± 3.98 (n = 174) | 4.22 ± 2.48 (n = 172) | 4.29 ± 2.96 (n = 171) |
| Week 3 | 20.46 ± 12.38 (n = 173) | 30.66 ± 17.24 (n = 169) | 35.05 ± 17.30 (n = 167) |
| Week 7 | 20.86 ± 11.69 (n = 173) | 25.02 ± 12.59 (n = 168) | 28.97 ± 21.10 (n = 167) |
| TIBC, g/dL | |||
| Baseline | 436.6 ± 48.6 (n = 174) | 428.7 ± 44.0 (n = 172) | 429.8 ± 40.5 (n = 171) |
| Week 3 | 404.6 ± 48.1 (n = 173) | 365.1 ± 41.7 (n = 169) | 382.6 ± 41.5 (n = 167) |
| Week 7 | 372.7 ± 47.1 (n = 173) | 340.5 ± 45.1 (n = 167) | 346.8 ± 38.7 (n = 167) |
| TSAT, % | |||
| Baseline | 4.6 ± 4.7 (n = 174) | 4.2 ± 2.1 (n = 172) | 3.9 ± 1.8 (n = 171) |
| Week 3 | 10.4 ± 6.6 (n = 173) | 20.8 ± 13.4 (n = 169) | 13.8 ± 6.7 (n = 167) |
| Week 7 | 14.6 ± 8.8 (n = 173) | 23.4 ± 12.0 (n = 167) | 19.0 ± 12.1 (n = 167) |
| Hepcidin-25, ng/L | |||
| Baseline | 208.7 ± 301.4 (n = 174) | 213.1 ± 317.5 (n = 172) | 364.3 ± 1362.1 (n = 171) |
| Week 7 | 4166.1 ± 7987.1 (n = 173) | 9173.2 ± 7997.5 (n = 168) | 7439.1 ± 9891.3 (n = 167) |
| sTfR, nmol/L | |||
| Baseline | 44.75 ± 14.17 (n = 174) | 46.36 ± 16.31 (n = 172) | 44.84 ± 18.29 (n = 171) |
| Week 7 | 24.52 ± 7.82 (n = 173) | 21.82 ± 6.95 (n = 168) | 22.48 ± 6.98 (n = 167) |
| Phosphorus, mg/dL | |||
| Baseline | 3.50 ± 0.45 (n = 174) | 3.55 ± 0.50 (n = 172) | 3.57 ± 0.46 (n = 171) |
| Week 3 | 3.59 ± 0.47 (n = 174) | 3.61 ± 0.52 (n = 170) | 3.59 ± 0.46 (n = 170) |
| Week 7 | 3.62 ± 0.50 (n = 173) | 3.65 ± 0.51 (n = 168) | 3.62 ± 0.49 (n = 168) |
Data are presented as mean ± standard deviation
mITT modified intention-to-treat, RBC red blood cells, Hct hematocrit, MCV mean corpuscular volume, Retic reticulocytes, TIBC total iron-binding capacity, TSAT transferrin saturation, sTfR soluble transferrin receptor, FC-low group ferric citrate hydrate at 500 mg/day, FC-high group ferric citrate hydrate at 1000 mg/day, SF group sodium ferrous citrate at 100 mg/day