Table 1.
Baseline Characteristics of the Patients in the Intention-to-Treat Population.*
| Characteristic | Placebo (N = 1097) | Bardoxolone Methyl (N = 1088) | All Patients (N = 2185) |
|---|---|---|---|
| Age — yr | 68.2±9.4 | 68.9±9.7 | 68.5±9.6 |
| Female sex — no. (%) | 472 (43) | 462 (42) | 934 (43) |
| Race — no. (%)† | |||
| White | 848 (77) | 846 (78) | 1694 (78) |
| Black | 176 (16) | 185 (17) | 361 (17) |
| Other | 73 (7) | 57 (5) | 130 (6) |
| Hispanic ethnic group — no. (%)† | 184 (17) | 186 (17) | 370 (17) |
| Region — no. (%) | |||
| United States | 772 (70) | 773 (71) | 1545 (71) |
| European Union | 169 (15) | 165 (15) | 334 (15) |
| Australia | 67 (6) | 66 (6) | 133 (6) |
| Canada | 46 (4) | 41 (4) | 87 (4) |
| Israel | 23 (2) | 23 (2) | 46 (2) |
| Mexico | 20 (2) | 20 (2) | 40 (2) |
| Weight — kg | 95.3±21.1 | 95.1±22.0 | 95.2±21.5 |
| Glycated hemoglobin — % | 7.1±1.2 | 7.2±1.3 | 7.1±1.2 |
| Serum creatinine — mg/dl | 2.7±0.6 | 2.7±0.6 | 2.7±0.6 |
| Estimated GFR — ml/min/1.73 m2 | 22.5±4.6 | 22.4±4.3 | 22.5±4.5 |
| Urinary albumin-to-creatinine ratio‡ | |||
| Median | 351 | 292 | 320 |
| Interquartile range | 60–1136 | 53–1151 | 57–1140 |
| Diabetes history | |||
| Time since diabetes diagnosis — yr | 18.1±9.7 | 18.9±9.7 | 18.5±9.7 |
| Retinopathy — no. (%) | 445 (41) | 446 (41) | 891 (41) |
| Neuropathy — no. (%) | 500 (46) | 517 (48) | 1017 (47) |
| Amputation — no. (%) | 49 (4) | 57 (5) | 106 (5) |
| Foot ulcer — no./total no. (%) | 37/428 (9) | 36/433 (8) | 73/861 (8) |
| Cardiovascular history — no. (%) | |||
| Any history of cardiovascular disease | 619 (56) | 609 (56) | 1228 (56) |
| Hospitalization for heart failure | 118 (11) | 120 (11) | 238 (11) |
*
Plus–minus values are means ±SD. There were no significant between-group differences at baseline. To convert the values for creatinine to micromoles per liter, multiply by 88.4. GFR denotes glomerular filtration rate.
†
Race or ethnic group was self-reported. Patients of any race could identify themselves as Hispanic.
‡
The ratio is based on measurement of albumin in milligrams and creatinine in grams.