Table 1.
Baseline characteristics of the patients in the intention-to-treat population
| Characteristic | Placebo (n=80) | Bardoxolone Methyl (n=77) |
|---|---|---|
| Age (yr), mean (SD) | 40 (16) | 39 (15) |
| Age <18 years, n (%) | 12 (15) | 11 (14) |
| Female, n (%) | 48 (60) | 43 (56) |
| Race, n (%) | ||
| American Indian or Alaska Native | 1 (1) | 0 |
| Asian | 12 (15) | 14 (18) |
| Black or African American | 2 (3) | 3 (4) |
| White | 63 (79) | 55 (71) |
| Native Hawaiian or Other Pacific Islander | 0 | 1 (1) |
| Other | 2 (3) | 4 (5) |
| Hispanic or Latino, n (%) | 10 (13) | 9 (12) |
| Baseline eGFR (ml/min per 1.73 m2), mean (SD); range (min–max) | 63 (18); 28–91 | 63 (18); 30–97 |
| eGFR category, n (%) | ||
| ≤60 ml/min per 1.73 m2 | 33 (41) | 33 (43) |
| >60 ml/min per 1.73 m2 | 47 (59) | 44 (57) |
| Baseline UACR (mg/g), geometric mean (SEM) | 134 (33) | 148 (34) |
| Baseline UACR ≤300 mg/g, n (%) | 43 (54) | 42 (55) |
| Baseline UACR >300 mg/g, n (%) | 37 (46) | 35 (46) |
| Baseline hematuria present, n (%) | 68 (85) | 67 (87) |
| Hearing loss (yes), n (%) | 34 (43) | 36 (47) |
| Visual impairment (yes), n (%) | 19 (24) | 18 (23) |
| Age at diagnosis (yr), mean (SD) | 30 (19) | 30 (17) |
| Histologic diagnosis (yes), n (%) | 15 (19) | 17 (22) |
| Genetic diagnosis, n (%) | ||
| X-linked AS subtype | 51 (64) | 47 (61) |
| Males with X-linked AS subtype | 21 (26) | 23 (30) |
| Females with X-linked AS subtype | 30 (38) | 24 (31) |
| Non–X-linked AS subtype | 24 (30) | 24 (31) |
| ACE inhibitor/ARB use (yes), n (%) | 60 (75) | 62 (81) |
| Body mass index (kg/m2), mean (SD) | 26 (6) | 27 (6) |
min, minimum; max, maximum; UACR, urinary albumin-creatinine ratio; AS, Alport syndrome; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker.