Table 3.

Changes from baseline in mean local hemoglobin at evaluation period by starting dose in DIALOGUE 1, DIALOGUE 2, and DIALOGUE 4

Within-Group Change from BaselineBetween-Group Comparison
Starting Dose GroupnBaseline MeanEvaluation Period MeanLS Mean Change95% CI for LS Mean ChangeDifference in LS Mean Change95% CI for Difference
DIALOGUE 1
 Molidustat 25 mg once daily129.510.91.4(0.7 to 2.1)1.3(0.5 to 2.0)
 Molidustat 50 mg once daily119.711.11.5(0.7 to 2.3)1.3(0.5 to 2.0)
 Molidustat 75 mg once daily510.011.81.8(0.9 to 2.7)1.7(0.7 to 2.7)
 Molidustat 25 mg twice daily139.411.11.5(0.8 to 2.3)1.5(0.7 to 2.2)
 Molidustat 50 mg twice daily99.411.22.0(1.1 to 2.8)1.7(0.8 to 2.5)
 Molidustat combined509.511.11.6(1.2 to 2.0)1.4(0.9 to 2.0)
 Placebo199.69.70.2(−0.4 to 0.7)
DIALOGUE 2
 Molidustat 25 mg once daily2611.011.10.4(−0.1 to 1.0)0.0(−0.4 to 0.5)
 Molidustat 50 mg once daily2610.811.20.5(0.1 to 0.9)0.2(−0.2 to 0.6)
 Molidustat 75 mg once daily2810.711.50.9(0.5 to 1.3)0.6(0.2 to 0.9)
 Molidustat combined8010.811.30.5(0.2 to 0.9)0.2(−0.1 to 0.6)
 Darbepoetin2810.911.10.3(−0.1 to 0.7)
DIALOGUE 4
 Molidustat 25 mg once daily3210.49.6−2.4(−3.4 to −1.4)−0.8(−1.3 to −0.4)
 Molidustat 50 mg once daily2710.49.9−2.2(−3.2 to −1.2)−0.5(−1.0 to −0.0)
 Molidustat 75 mg once daily3210.510.4−0.1(−1.0 to 0.7)−0.1(−0.6 to 0.4)
 Molidustat 150 mg once daily2010.710.7−0.8(−1.4 to −0.1)0.4(−0.1 to 0.8)
 Molidustat combined11110.510.1−0.7(−1.3 to 0.0)−0.3(−0.7 to 0.1)
 Epoetin3910.610.4−0.4(−1.1 to 0.4)
  • n is number of subjects at evaluation period. LS mean and difference in LS mean are on the basis of analysis of covariance model including treatment, randomization stratification, factors, and baseline as a covariate. DIALOGUE, DaIly orAL treatment increasing endOGenoUs Erythropoietin; LS, least square; 95% CI, 95% confidence interval.