Table 3.
Hemoglobin response analysis during the first 24 weeks of treatment, censoring for rescue therapy by study and for pooled data in patients with non–dialysis-dependent CKD (full analysis set)
| Hemoglobin Response | Study 608 | Study 060 | Study 001 | Pooled Data | |||||
| Roxadustat (n=389) |
Placebo (n=203) |
Roxadustat (n=608) |
Placebo (n=305) |
Roxadustat (n=1371) |
Placebo (n=1357) |
Roxadustat (n=2368) |
Placebo (n=1865) |
||
| Patients achieving a Hb response, n (%) a | 308 (79) | 20 (10) | 523 (86) | 20 (7) | 1055 (77) | 115 (9) | 1899 (80) | 163 (9) | |
| 95% CIb | 75 to 83 | 6 to 15 | 83 to 89 | 4 to 10 | 75 to 79 | 7 to 10 | 79 to 82 | 8 to 10 | |
| Treatment group difference (95% CI) | 69 (64 to 75) | 80 (76 to 83) | 69 (66 to 71) | 72 (69 to 74) | |||||
| OR (95% CI) c | 34.7 (20.5 to 58.9)d | 77.6 (44.7 to 134.5) | 36.5 (28.5 to 46.7) | 40.5 (33.0 to 49.7) | |||||
| P value | <0.001 | <0.001 | <0.001 | ||||||
Hb values under the influence of a rescue therapy were censored up to 6 weeks. Hb, hemoglobin; 95% CI, 95% confidence interval; OR, odds ratio; CMH, Cochran–Mantel–Haenszel.
Hb response defined as Hb ≥11.0 g/dl, and Hb increase from baseline ≥1.0 g/dl in patients with baseline Hb >8.0 g/dl, or Hb increase ≥2.0 g/dl in patients with baseline Hb ≤8.0 g/dl at two consecutive visits ≥5 days apart during the first 24 weeks of treatment without rescue therapy.
On the basis of the exact method of Clopper–Pearson.
CMH method adjusting for study, region (United States, Europe, other); baseline Hb (<8.0 versus ≥8.0 g/dl); baseline eGFR (<30 versus ≥30 ml/min per 1.73 m2); and history of cardiovascular, cerebrovascular, or thromboembolic diseases (yes versus no).
CMH test was performed.