Table 3.

Iron parameters at end of treatment (intent-to-treat population)

Iron ParameterDaprodustat, n=133Darbepoetin Alfa, n=134
n115120
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.