Table 2.
Blood chemistry before (day −7, baseline visit) and 1 week after (day 7, final study visit) administration of FG-2216
| Laboratory Parameter (Normal Range) | Baseline (Day −7) |
End of Study (Day 7) |
||||
|---|---|---|---|---|---|---|
| Control Subjects | Nephric HD Patients | Anephric HD Patients | Control Subjects | Nephric HD Patients | Anephric HD Patients | |
| AST (IU/L; <31) | 24.5 ± 9.5 | 14.8 ± 4.8 | 24.5 ± 13.3 | 27.0 ± 5.6 | 12.8 ± 4.7 | 24.8 ± 15.0 |
| ALT (IU/L; <34) | 35.5 ± 20.9 | 13.7 ± 8.8 | 14.0 ± 3.7 | 34.8 ± 17.7 | 19.2 ± 6.6 | 13.5 ± 4.8 |
| Total bilirubin (mg/dl; 0.1 to 1.1) | 0.65 ± 0.32 | 0.57 ± 0.16 | 0.72 ± 0.23 | 0.60 ± 0.32 | 0.57 ± 0.15 | 0.61 ± 0.20 |
| Albumin (g/L; 35 to 55) | 41.7 ± 1.6 | 42.0 ± 1.3 | 40.8 ± 5.8 | 42.3 ± 1.3 | 40.2 ± 4.7 | 37.6 ± 4.8 |
| AP (U/L; 42 to 98) | 76.7 ± 19.2 | 99.8 ± 14.3 | 88.2 ± 29.5 | 75.8 ± 14.6 | 89.3 ± 15.2 | 87.0 ± 15.8 |
| Lipase (U/L; <60) | 21.2 ± 17.5 | 56.7 ± 25.2 | 66.8 ± 30.2 | 21.2 ± 10.8 | 61.5 ± 24.8 | 76.0 ± 34.4 |
| Hb (g/dl; 12 to 16) | 15.40 ± 0.70 | 13.30 ± 1.60 | 14.00 ± 1.30 | 15.60 ± 1.20 | 12.20 ± 1.51 | 12.20 ± 1.20 |
| Ferritin (22 to 112) | 168 ± 124 | 1108 ± 496 | 975 ± 630 | 173 ± 146 | 1210 ± 615 | 1001 ± 682 |
| Transferrin saturation (%; 16 to 45) | 30.7 ± 13.1 | 35.1 ± 11.6 | 39.9 ± 11.6 | 26.8 ± 7.3 | 41.5 ± 29.1 | 50.1 ± 6.5 |
When baseline levels at screening visit were compared with measurements 1 week after study drug administration, FG-2216 caused no significant changes in liver parameters, Hb, iron parameters, or lipid profile. Data are means ± SD (n = 6 per group). AST, aspartate transaminase; ALT, alanine transaminase; AP, alkaline phosphatase.