| |
Hb (g/dL) |
Reticulocyte count (103/μL) |
CHr (pg) |
TIBC (μg/dL) |
S-ferritin (ng/mL) |
TSAT(%) |
| 100 mg iron isomaltoside 1000, mean (SD) |
| Baseline |
11.20 (0.60) |
52.57 (12.28) |
31.92 (2.08) |
244.00 (25.88) |
564.20 (136.66) |
18.80 (6.38) |
| 4 h |
0.30 (0.38) |
1.45 (9.48) |
-0.17 (0.30) |
-12.80 (17.40) |
-29.80(86.90) |
37.60 (8.91) |
| 8 h |
0.25 (0.2) |
5.08 (8.94) |
-0.07 (0.23) |
-8.60 (22.65) |
7.80 (23.40) |
36.00 (4.69) |
| 24 h |
-0.15 (0.49) |
-8.20 (10.11) |
-0.48 (0.42) |
-7.40 (20.82) |
41.0 (84.68) |
25.20 (10.08) |
| 48 h |
0.33 (0.32) |
0.55 (16.0) |
-0.47 (0.74) |
-3.20 (20.74) |
83.60 (67.33) |
18.40 (3.36) |
| 72 h |
-0.07 (0.36) |
-5.78 (15.67) |
-0.02 (0.80) |
-6.20 (16.78) |
32.60 (39.32) |
10.20 (8.87) |
| 7 days |
-0.30 (0.55) |
-0.58 (11.70) |
0.23 (0.64) |
-11.0 (22.27) |
29.80 (32.28) |
-0.20 (3.27) |
| 200 mg iron isomaltoside 1000, mean (SD) |
| Baseline |
10.73 (0.40) |
41.45 (10.44) |
31.92 (1.59) |
233.67 (36.48) |
698.33 (69.76) |
37.33 (22.63) |
| 4 h |
0.32 (0.44) |
6.87 (8.37) |
0.23 (0.53) |
2.83 (9.64) |
37.50 (50.68) |
61.17 (40.20) |
| 8 h |
0.60 (0.36) |
8.50 (5.09) |
0.22 (0.19) |
13.17 (6.91) |
117.83 (108.06) |
53.67 (42.87) |
| 24 h |
0.20 (0.22) |
5.75 (7.98) |
0.37 (0.50) |
7.83 (10.61) |
37.50 (73.52) |
31.33 (34.56) |
| 48 h |
0.75 (0.48) |
2.42 (8.29) |
0.12 (0.32) |
15.67 (9.40) |
169.83 (176.50) |
11.00 (27.52) |
| 72 h |
0.43 (0.38) |
0.72 (20.18) |
0.35 (1.23) |
10.33 (10.95) |
168.83 (94.09) |
2.17 (29.31) |
| 7 days |
-0.07 (0.54) |
11.23 (19.27) |
0.72 (1.04) |
6.17 (11.81) |
83.67 (96.18) |
-10.33 (28.37) |
| 500 mg iron isomaltoside 1000, mean (SD) |
| Baseline |
11.22 (0.84) |
85.20 (49.85) |
30.98 (1.20) |
232.33 (32.87) |
369.67 (205.19) |
21.83 (6.24) |
| 4 h |
0.40 (0.52) |
-2.32 (30.30) |
0.28 (0.37) |
-10.00 (28.19) |
4.5 (66.79) |
140.50 (39.01) |
| 8 h |
0.50 (0.36) |
-5.42 (32.28) |
0.32 (0.45) |
7.17 (14.93) |
-3.5 (28.24) |
133.00 (43.23) |
| 24 h |
-0.00 (0.77) |
-7.27 (24.08) |
0.43 (0.74) |
-29.83 (95.14) |
-0.83 (95.18) |
98.50 (29.75) |
| 48 h |
0.37 (0.56) |
-29.67 (32.21) |
0.43 (0.81) |
34.17 (52.69) |
155.83 (59.18) |
58.67 (22.42) |
| 72 h |
0.07 (0.36) |
-22.85 (26.19) |
0.95 (0.42) |
4.67 (4.03) |
156.50 (104.57) |
35.17 (16.22) |
| 7 days |
0.02 (0.64) |
-11.87 (30.54) |
1.43 (2.22) |
10.33 (23.19) |
216.67 (116.66) |
4.33 (8.24) |
|
| CHr: Reticulocyte hemoglobin count; Hb: hemoglobin; TIBC: total iron binding capacity; TSAT: transferrin saturation |
| Table 3: Baseline values and change in concentrations of pharmacodynamic parameters from baseline to 4 h, 8 h, 24 h, 48 h, 72 h and 7 days post-dose. |
