Table 4.
Laboratory parameters: estimated effect size and its precision, Group A versus B
| Laboratory parameter, time point (number of patients) | Iron isomaltoside 1000 (Group A), least-square mean estimatea | Iron sulphate (Group B), least-square mean estimatea | Difference estimates (95% CI) | P value |
|---|---|---|---|---|
| Hb (g/dL)—FAS | ||||
| Week 2 (Group A: 210, Group B: 110) | 0.33 | 0.27 | 0.059 (−0.11; 0.23) | 0.49 |
| Week 4 (Group A: 209, Group B: 108) | 0.60 | 0.37 | 0.22 (0.012; 0.43) | <0.001/0.039b |
| Week 8 (Group A: 210, Group B: 112) | 0.94 | 0.49 | 0.45 (0.20; 0.69) | <0.001 |
| Hb (g/dL)—PP analysis set | ||||
| Week 4 (Group A: 204, Group B: 106) | 0.61 | 0.39 | 0.22 (0.003; 0.43) | <0.001/0.047b |
| Serum iron (µg/dL)—FAS | ||||
| Week 1 (Group A: 217, Group B: 109) | 6.22 | 2.66 | 3.55 (1.80; 5.31) | <0.001 |
| Week 2 (Group A: 209, Group B: 110) | 4.05 | 2.02 | 2.03 (0.72; 3.34) | 0.003 |
| Week 4 (Group A: 208, Group B: 108) | 2.89 | 1.99 | 0.90 (−0.31; 2.10) | 0.14 |
| Week 8 (Group A: 209, Group B: 112) | 2.81 | 1.86 | 0.95 (−0.16; 2.06) | 0.091 |
| Serum ferritin (ng/mL)—FAS | ||||
| Week 1 (Group A: 217, Group B: 109) | 353 | 32 | 321 (270; 373) | <0.001 |
| Week 2 (Group A: 209, Group B: 110) | 387 | 52 | 335 (252; 418) | <0.001 |
| Week 4 (Group A: 208, Group B: 108) | 289 | 54 | 235 (170; 301) | <0.001 |
| Week 8 (Group A: 209, Group B: 112) | 222 | 66 | 156 (105; 206) | <0.001 |
| TSAT (%)—FAS | ||||
| Week 1 (Group A: 217, Group B: 109) | 11.01 | 2.64 | 8.37 (5.17; 11.57) | <0.001 |
| Week 2 (Group A: 209, Group B: 110) | 8.34 | 2.14 | 6.20 (3.86; 8.54) | <0.001 |
| Week 4 (Group A: 208, Group B: 108) | 7.34 | 2.57 | 4.77 (2.45; 7.08) | <0.001 |
| Week 8 (Group A: 209, Group B: 112) | 6.73 | 3.54 | 3.20 (1.06; 5.33) | 0.004 |
| TIBC (µmol/L)—FAS | ||||
| Week 1 (Group A: 217, Group B: 109) | −4.64 | −0.72 | −3.92 (−5.43; −2.41) | <0.001 |
| Week 2 (Group A: 209, Group B: 110) | −7.52 | −2.33 | −5.18 (−7.01; −3.36) | <0.001 |
| Week 4 (Group A: 208, Group B: 108) | −9.85 | −2.70 | −7.16 (−8.99; −5.32) | <0.001 |
| Week 8 (Group A: 209, Group B: 112) | −9.97 | −5.19 | −4.78 (−6.35; −3.20) | <0.001 |
Conversion factor for serum iron: µmol/L/0.179 = µg/dL.
aLeast-square means from repeated measures model with treatment, visit, treatment × visit interactions, country and stratum [past treatment with parenteral iron (yes/no) and current eGFR between 15 and 45 mL/min/1.73 m2 or 46 and 59 mL/min/1.73 m2] as factors and baseline Hb as covariate.
bThe first P-value represents the non-inferiority test and the second P-value represents the superiority test.