Table 3.
Iron parameters at end of treatment (intent-to-treat population)
| Iron Parameter | Daprodustat, n=133 | Darbepoetin Alfa, n=134 |
|---|---|---|
| n | 115 | 120 |
| TSAT at wk 52, %a | ||
| Mean (SD) | 27.0 (12.3) | 24.6 (9.1) |
| Change from baseline (SD) | 0.3 (13.2) | −2.1 (11.4) |
| Adjusted treatment difference (95% CI) | 2.8 (0.1 to 5.4) | |
| TIBC at wk 52, µg/dl | ||
| Mean (SD) | 303 (64) | 257 (44) |
| Change from baseline (SD) | 49 (56) | 6 (34) |
| Treatment difference (95% CI) | 41 (30 to 53) | |
| Serum iron at wk 52, µg/dl | ||
| Mean (SD) | 78 (29) | 63 (24) |
| Change from baseline (SD) | 11 (34) | −4 (28) |
| Treatment difference (95% CI) | 16 (10 to 22) | |
| Ferritin, µg/Lb | ||
| Geometric mean (CV %) | 66.7 (143.5) | 74.9 (127.8) |
| Percent change from baseline (CV %) | −22 (132.2) | −20 (124.1) |
| Adjusted ratio for percent change from baseline (95% CI) | 0.95 (0.75 to 1.19) | |
| Hepcidin, ng/mlb | ||
| Geometric mean (CV %) | 37.9 (103.8) | 51.5 (111.5) |
| Percent change from baseline (CV %) | −37 (116.1) | −20 (133.6) |
| Adjusted ratio for percent change from baseline (95% CI) | 0.74 (0.57 to 0.95) | |
TSAT, transferrin saturation; 95% CI, 95% confidence interval; TIBC, total iron-binding capacity; CV %, coefficient of variation.
a
The distribution in TSAT had been assumed to be skewed but was found not to be skewed after the data review; therefore, the analysis of TSAT on the basis of a nonlog transformation was done as a post hoc analysis.
b
The distributions were assumed to be skewed and required a log transformation for the analysis. The distribution in ferritin had been assumed not to be skewed but was found to be skewed after the data review; therefore, the analysis of ferritin on the basis of a log transformation was done as a post hoc analysis.