Table 2.

Entry Characteristics of study participants who completed study

CharacteristicsPlaceboPirfenidone at 1200 mg/dPirfenidone at 2400 mg/dP
n211714
Age (years)59 ± 1258 ± 1055 ± 130.56
Male n (%)12 (57%)11 (65%)10 (71%)0.69
Black n (%)6 (29%)7 (41%)2 (21%)0.48
Weight (pounds)210 ± 50206 ± 28218 ± 490.74
BMI (kg/m2)31.9 ± 7.231.5 ± 5.332.8 ± 8.20.88
Systolic BP (mmHg)129 ± 15123 ± 9130 ± 100.24
Diastolic BP (mmHg)71 ± 970 ± 878 ± 70.02
Heart rate (bpm)71 ± 870 ± 1271 ± 130.94
DM type 2, n %16 (76%)13 (76%)11 (79%)0.99
DM duration (years)24 ± 1318 ± 1019 ± 90.25
ACEI/ARB use n (%)0.55
    ACEI only6 (29%)7 (41%)4 (29%)
    ARB only10 (48%)3 (18%)5 (36%)
    ACEI + ARB4 (19%)6 (35%)5 (36%)
Smoking n (%)0.68
    current1 (5%)0 (0%)0 (0%)
    former11 (52%)8 (50%)5 (38%)
Hemoglobin A1c (g/dl)7.3 ± 1.47.4 ± 1.27.1 ± 1.40.81
HDL-cholesterol (mg/dl)45 ± 1144 ± 943 ± 120.86
LDL-cholesterol (mg/dl)96 ± 28108 ± 39104 ± 240.53
Triglycerides (mg/dl)a104 (70, 171)116 (76, 188)109 (88, 157)0.83
Serum albumin (g/dl)4.4 ± 0.34.6 ± 0.44.2 ± 0.40.04
eGFR (ml/min per 1.73 m2)39 ± 1338 ± 1339 ± 130.95
Urine ACR (mg/g)a79 (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.