Table 5.
Statistical analysis of change in Hb levels from baseline to the average of weeks 28–52 regardless of rescue therapya (all randomized patients)
| Roxadustat (n = 415) | ESA (n = 421) | |
|---|---|---|
| Baseline Hb, g/dL | 10.747 (0.617) | 10.775 (0.621) |
| N | 414 | 420 |
| Average Hb (weeks 28–52), g/dL | 11.145 (0.615) | 10.960 (0.660) |
| N | 364 | 393 |
| Hb change from BL to average of weeks 28–52 | 0.397 (0.773) | 0.183 (0.860) |
| LSM (95% CI)b | 0.363 (0.288, 0.438) | 0.192 (0.121, 0.262) |
| N (imputed values) | 413 | 420 |
| LSM difference (roxadustat − ESA) | 0.171 (0.082, 0.261) | |
| Two-sided P-value (superiority) | < 0.001 | |
Data are reported as mean (standard deviation) unless otherwise indicated
BL baseline, CI confidence interval, ESA erythropoiesis-stimulating agent, Hb hemoglobin, LSM least squares mean
For the ANCOVA with multiple imputation analysis, missing post-baseline values are imputed where Hb values averaged over 1000 simulations
aOne course of rescue ESA was allowed in patients taking roxadustat if the Hb level had not responded adequately (< 9.0 g/dL) after at least two roxadustat dose increases in the previous 8 weeks, or if the roxadustat dose had reached the maximum limit