Table 1.
Baseline characteristics and demographics of randomized patients
| Variable | Placebo (n=103) | TGF-β1 mAb | Total (n=416) | P-Valuea | ||
|---|---|---|---|---|---|---|
| 2 mg (n=105) | 10 mg (n=103) | 50 mg (n=105) | ||||
| Sex, n (%) | 0.25 | |||||
| Men | 76 (73.8) | 84 (80.0) | 74 (71.8) | 86 (81.9) | 320 (76.9) | |
| Women | 27 (26.2) | 21 (20.0) | 29 (28.2) | 19 (18.1) | 96 (23.1) | |
| Age, yr | 62.7±11.3 | 62.8±9.2 | 60.5±9.1 | 62.9±10.9 | 62.2±10.2 | 0.27 |
| Race, n (%) | 0.33 | |||||
| American Indian or Alaska Native | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Asian | 0 (0.0) | 4 (3.8) | 2 (1.9) | 2 (1.9) | 8 (1.9) | |
| Black | 14 (13.6) | 9 (8.6) | 9 (8.7) | 7 (6.7) | 39 (9.4) | |
| Multiple | 1 (1.0) | 0 (0.0) | 2 (1.9) | 0 (0.0) | 3 (0.7) | |
| Native Hawaiian or other Pacific Islander | 1 (1.0) | 0 (0.0) | 1 (1.0) | 0 (0.0) | 2 (0.5) | |
| White | 83 (80.6) | 90 (85.7) | 84 (81.6) | 90 (85.7) | 347 (83.4) | |
| Not provided | 4 (3.9) | 2 (1.9) | 5 (4.9) | 6 (5.7) | 17 (4.1) | |
| Body mass index, kg/m2 | 34.0±6.6 | 33.4±6.0 | 34.7±7.2 | 33.3±6.8 | 33.9±6.7 | 0.41 |
| Systolic BP, mmHg | 139.8±12.3 | 137.6±14.9 | 138.2±12.5 | 136.7±13.6 | 138.1±1 3.4 | 0.4 |
| Diastolic BP, mmHg | 75.5±8.5 | 74.2±9.6 | 74.3±9.0 | 73.1±9.8 | 74.3±9.3 | 0.35 |
| Type 2 diabetes, n (%) | 93 (90.3) | 92 (87.6) | 92 (89.3) | 93 (88.6) | 370 (88.9) | 1.0 |
| Duration of diabetes, d | 7073.9 (3381.6) | 6610.1 (3324.5) | 6957.0 (3069.9) | 7110.8 (3686.5) | ||
| Duration of kidney disease, d | 1922.4 (1405.0) | 1802.3 (1655.9) | 2041.3 (1527.3) | 2133.1 (2318.4) | ||
| Hemoglobin A1c, % | 7.8±1.8 | 7.9±1.8 | 7.9±1.6 | 7.9±1.7 | 7.9±1.7 | 0.96 |
| SCr, mg/dl | 2.2±0.6 | 2.1±0.6 | 2.1±0.7 | 2.1±0.6 | 2.1±0.6 | 0.57 |
| eGFR, ml/min per 1.73 m2 | 33.8±11.1 | 35.7±11.7 | 36.4±12.5 | 35.9±12.1 | 35.5±11.9 | 0.43 |
| UPCR, g/g | 3.1±2.5 | 3.3±2.6 | 3.3±2.5 | 3.4±2.5 | 3.3±2.5 | 0.92 |
Data are means±SD unless otherwise indicated. Summary for SCr was on the basis of the imputed values. Baseline UPCR is the mean of the available values at the last visit obtained on or before the first date of administration of investigational drug. The baseline value for other parameters is the last available value obtained on or before the first date of administration of investigational drug.
a
P values for continuous variables were obtained using one-way ANOVA, with treatment as main effect. P values for categorical variables were obtained using Fisher exact test.