Table 2.
Entry Characteristics of study participants who completed study
| Characteristics | Placebo | Pirfenidone at 1200 mg/d | Pirfenidone at 2400 mg/d | P |
|---|---|---|---|---|
| n | 21 | 17 | 14 | |
| Age (years) | 59 ± 12 | 58 ± 10 | 55 ± 13 | 0.56 |
| Male n (%) | 12 (57%) | 11 (65%) | 10 (71%) | 0.69 |
| Black n (%) | 6 (29%) | 7 (41%) | 2 (21%) | 0.48 |
| Weight (pounds) | 210 ± 50 | 206 ± 28 | 218 ± 49 | 0.74 |
| BMI (kg/m2) | 31.9 ± 7.2 | 31.5 ± 5.3 | 32.8 ± 8.2 | 0.88 |
| Systolic BP (mmHg) | 129 ± 15 | 123 ± 9 | 130 ± 10 | 0.24 |
| Diastolic BP (mmHg) | 71 ± 9 | 70 ± 8 | 78 ± 7 | 0.02 |
| Heart rate (bpm) | 71 ± 8 | 70 ± 12 | 71 ± 13 | 0.94 |
| DM type 2, n % | 16 (76%) | 13 (76%) | 11 (79%) | 0.99 |
| DM duration (years) | 24 ± 13 | 18 ± 10 | 19 ± 9 | 0.25 |
| ACEI/ARB use n (%) | 0.55 | |||
| ACEI only | 6 (29%) | 7 (41%) | 4 (29%) | |
| ARB only | 10 (48%) | 3 (18%) | 5 (36%) | |
| ACEI + ARB | 4 (19%) | 6 (35%) | 5 (36%) | |
| Smoking n (%) | 0.68 | |||
| current | 1 (5%) | 0 (0%) | 0 (0%) | |
| former | 11 (52%) | 8 (50%) | 5 (38%) | |
| Hemoglobin A1c (g/dl) | 7.3 ± 1.4 | 7.4 ± 1.2 | 7.1 ± 1.4 | 0.81 |
| HDL-cholesterol (mg/dl) | 45 ± 11 | 44 ± 9 | 43 ± 12 | 0.86 |
| LDL-cholesterol (mg/dl) | 96 ± 28 | 108 ± 39 | 104 ± 24 | 0.53 |
| Triglycerides (mg/dl)a | 104 (70, 171) | 116 (76, 188) | 109 (88, 157) | 0.83 |
| Serum albumin (g/dl) | 4.4 ± 0.3 | 4.6 ± 0.4 | 4.2 ± 0.4 | 0.04 |
| eGFR (ml/min per 1.73 m2) | 39 ± 13 | 38 ± 13 | 39 ± 13 | 0.95 |
| Urine ACR (mg/g)a | 79 (36, 514) | 131 (48, 450) | 252 (118, 984) | 0.38 |
Baseline demographic, clinical, and laboratory parameters for study completers are presented. Data are presented as mean ± SD, with analysis by χ2 or Fisher's exact tests for categorical variables and ANOVA for continuous variables,
aexcept for variables for which data were not normally distributed, which are presented as median and IQR and were analyzed by Kruskal–Wallis test.