Table 1. Baseline Demographics and Laboratory Parameters.
| Trial A | Trial B | Pooled | ||||
|---|---|---|---|---|---|---|
| Iron Isomaltoside (n = 63) | Ferric Carboxymaltose (n = 60) | Iron Isomaltoside (n = 62) | Ferric Carboxymaltose (n = 57) | Iron Isomaltoside (n = 125) | Ferric Carboxymaltose (n = 117) | |
| Patient Demographics | ||||||
| Age, mean (SD), y | 43.9 (10.4) | 46.3 (11.6) | 42.2 (12.9) | 43.1 (11.5) | 43.0 (11.7) | 44.7 (11.6) |
| Sex, No. (%) | ||||||
| Female | 61 (96.8) | 57 (95.0) | 58 (93.5) | 54 (94.7) | 119 (95.2) | 111 (94.9) |
| Male | 2 (3.2) | 3 (5.0) | 4 (6.5) | 3 (5.3) | 6 (4.8) | 6 (5.1) |
| Race, No. (%) | ||||||
| White | 38 (60.3) | 38 (63.3) | 28 (45.2) | 29 (50.9) | 66 (52.8) | 67 (57.3) |
| African American | 22 (34.9) | 19 (31.7) | 32 (51.6) | 27 (47.4) | 54 (43.2) | 46 (39.3) |
| Asian | 2 (3.2) | 1 (1.7) | 0 | 0 | 2 (1.6) | 1 (0.9) |
| Other | 1 (1.6) | 2 (3.3) | 2 (3.2) | 1 (1.8) | 3 (2.4) | 3 (2.6) |
| Hispanic ethnicity | 37 (58.7) | 36 (60.0) | 23 (37.1) | 23 (40.4) | 60 (48.0) | 59 (50.4) |
| Weight, mean (SD), kg | 80.6 (16.6) | 77.4 (20.2) | 90.1 (29.2) | 84.2 (20.1) | 85.3 (24.0) | 80.7 (20.3) |
| BMI, mean (SD) | 30.6 (6.1) | 29.6 (7.0) | 32.3 (8.6) | 31.7 (7.9) | 31.5 (7.5) | 30.7 (7.5) |
| Gynecological cause of IDA, No. (%) | 41 (65.1) | 42 (70.0) | 44 (71.0) | 39 (68.4) | 85 (68.0) | 81 (69.2) |
| Laboratory Parameters | ||||||
| Hemoglobin, mean (SD), g/dLa,b | 9.8 (1.3) | 9.6 (1.3) | 9.6 (1.2) | 9.3 (1.4) | 9.7 (1.3) | 9.5 (1.4) |
| Ferritin, median (IQR), ng/mLa,c | 6.1 (2.9-12.9) | 4.8 (3.1-7.5) | 4.8 (2.8-8.7) | 5.1 (2.7-8.8) | 5.2 (2.8-11.2) | 4.8 (3.0-7.7) |
| Transferrin saturation, median (IQR), %a,d | 5.6 (3.5-9.7) | 4.7 (3.6-7.7) | 5.2 (3.5-8.8) | 4.8 (3.2-9.2) | 5.3 (3.5-9.7) | 4.8 (3.4-8.1) |
| Serum phosphate, mean (SD), mg/dLe | 3.3 (0.6) | 3.3 (0.5) | 3.4 (0.5) | 3.3 (0.5) | 3.4 (0.5) | 3.3 (0.5) |
| Urinary fractional excretion of phosphate, mean (SD), %f | 11.1 (6.7) | 10.3 (4.7) | 9.4 (4.9) | 10.2 (4.5) | 10.3 (5.9) | 10.3 (4.6) |
| C-terminal FGF23, median (IQR), RU/mLg | 507 (225-1256) | 351 (186-857) | 579 (162-1317) | 454 (89-1344) | 539 (196-1257) | 398 (142-1192) |
| Intact FGF23, mean (SD), pg/mLg | 59.0 (39.8) | 46.2 (20.5) | 60.9 (50.3) | 53.6 (35.3) | 59.9 (45.2) | 49.9 (29.0) |
| Ionized calcium, mean (SD), mg/dLh | 5.1 (0.2) | 5.1 (0.2) | 5.1 (0.2) | 5.1 (0.2) | 5.1 (0.2) | 5.1 (0.2) |
| Intact parathyroid hormone, mean (SD), pg/mLi | 55.1 (26.4) | 51.6 (26.4) | 55.4 (26.5) | 59.9 (33.9) | 55.3 (26.3) | 55.7 (30.5) |
| 25-Hydroxyvitamin D, mean (SD), ng/mLj | 23.2 (7.6) | 25.9 (7.8) | 23.2 (11.0) | 23.8 (10.0) | 23.2 (9.4) | 25.0 (8.9) |
| 1,25-Dihydroxyvitamin D, mean (SD), pg/mLk | 58.9 (18.2) | 63.9 (19.4) | 55.6 (16.4) | 59.6 (19.6) | 57.3 (17.3) | 61.8 (19.5) |
| 24,25-Dihydroxyvitamin D, mean (SD), ng/mLl | 2.1 (1.1) | 2.4 (1.2) | 2.0 (1.6) | 1.9 (1.1) | 2.0 (1.4) | 2.2 (1.2) |
| Alkaline phosphatase, mean (SD), IU/Lm | 70.0 (26.9) | 72.4 (27.5) | 71.8 (18.5) | 76.9 (26.8) | 70.9 (23.1) | 74.6 (27.1) |
| Bone-specific alkaline phosphatase, mean (SD), μg/Ln | 11.6 (4.1) | 12.5 (6.6) | 12.0 (3.5) | 12.8 (5.9) | 11.8 (3.8) | 12.7 (6.3) |
| N-terminal propeptide of type 1 collagen, mean (SD), ng/mL | 56.5 (26.3) | 57.3 (28.9) | 58.4 (25.4) | 65.6 (39.4) | 57.4 (25.7) | 61.4 (34.5) |
| Carboxy-terminal collagen crosslinks, mean (SD), ng/mL | 0.33 (0.16) | 0.29 (0.15) | 0.33 (0.15) | 0.38 (0.22) | 0.33 (0.16) | 0.34 (0.20) |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); FGF23, fibroblast growth factor; IDA, iron-deficiency anemia; IQR, interquartile range.
SI conversion factors: To convert alkaline phosphatase to μkat/L, multiply by 0.0167; ferritin to pmol/L, multiply by 2.247; and ionized calcium to mmol/L, multiply by 0.25.
Data are presented for the as-randomized analysis set; all other data in the table are for the safety analysis set.
Reference range: women 18-59 y, 11.6-16.4 g/dL; men 18-59 y, 12.7-18.1 g/dL.
Reference range: women, 11.0-306.8 ng/mL; men, 23.9-336.2 ng/mL.
Calculcated as: (Total serum iron [μmol/L] × 5.586) / (transferrin [g/L] × 100) × 70.9.
Reference range: 2.2-5.1 mg/dL.
Calculcated as: (Urinary phosphate × serum creatinine) / (serum phosphate × urinary creatinine) × 100.
No reference range.
Reference range: 4.6-5.3 mg/dL.
Reference range: 14.0-72.0 pg/mL.
Reference range: 25.0-80.0 ng/mL.
Reference range: 20.8-105.4 pg/mL.
Reference range: 1.6-9.1 ng/mL.
Reference range: women 18-50 y, 31-106 IU/L; women 50-60 y, 35-123 IU/L; men 18-50 y, 31-129 IU/L; and men 50-60 y, 35-131 IU/L.
Reference range: premenopausal women, 2.9-14.5 μg/L; postmenopausal women, 3.8-22.6 μg/L; and men, 3.7-20.9 μg/L.