Table 5.
Baseline Renal Characteristics of the Randomized Placebo-Controlled Phase 2 or Phase 3 Population Minus Patients with Renal Dysfunction at Baseline (N = 2,008), the Subpopulation of Patients with Diabetes Minus Patients with Renal Dysfunction at Baseline (N = 733), and the Subpopulation of Patients with Renal Dysfunction at Baseline (N = 18)
| Phase 2 or phase 3a | Diabetic patientsa | Renal dysfunction at baseline | ||||
|---|---|---|---|---|---|---|
| Placebo (N = 642) | Total ASO (N = 1,366) | Placebo (N = 235) | Total ASO (N = 498) | Placebo (N = 6) | Total ASO (N = 12) | |
| Creatinine (mg/dL) | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 0.82 | 0.81 | 0.80 | 0.78 | 1.67 | 1.55 |
| SD, SEM | 0.18, 0.01 | 0.18, 0.01 | 0.19, 0.01 | 0.18, 0.01 | 0.67, 0.27 | 0.18, 0.05 |
| Mean 95% CI | 0.81, 0.84 | 0.80, 0.82 | 0.78, 0.83 | 0.76, 0.79 | 0.97, 2.37 | 1.43, 1.66 |
| eGFR (mL/min per 1.73 m2) | ||||||
| n | 637 | 1,343 | 233 | 496 | 6 | 12 |
| Mean | 97.8 | 98.4 | 99.5 | 102.4 | 45.3 | 46.6 |
| SD, SEM | 23.2, 0.9 | 23.6, 0.6 | 23.9, 1.6 | 25.4, 1.1 | 15.8, 6.4 | 12.6, 3.6 |
| Mean 95% CI | 96.0, 99.6 | 97.1, 99.7 | 96.4, 102.5 | 100.2, 104.7 | 28.8, 61.9 | 38.6, 54.5 |
| BUN (mg/dL) | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 15.2 | 15.0 | 15.3 | 15.0 | 30.9 | 31.5 |
| SD, SEM | 4.5, 0.2 | 4.4, 0.1 | 4.8, 0.3 | 4.6, 0.2 | 14.5, 5.9 | 12.6, 3.6 |
| Mean 95% CI | 14.9, 15.6 | 14.7, 15.2 | 14.7, 16.0 | 14.6, 15.4 | 15.7, 46.1 | 23.5, 39.5 |
| Albumin | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 4.5 | 4.4 | 4.4 | 4.4 | 4.1 | 4.2 |
| SD, SEM | 0.4, 0.0 | 0.4, 0.0 | 0.3, 0.0 | 0.4, 0.0 | 0.4, 0.1 | 0.5, 0.2 |
| Mean 95% CI | 4.4, 4.5 | 4.4, 4.5 | 4.4, 4.5 | 4.4, 4.5 | 3.7, 4.5 | 3.9, 4.6 |
| Potassium (mEq/L) | ||||||
| n | 636 | 1,339 | 233 | 496 | 6 | 12 |
| Mean | 4.3 | 4.3 | 4.3 | 4.3 | 4.3 | 4.3 |
| SD, SEM | 0.4, 0.0 | 0.4, 0.0 | 0.5, 0.0 | 0.4, 0.0 | 0.4, 0.2 | 0.5, 0.2 |
| Mean 95% CI | 4.3, 4.3 | 4.3, 4.3 | 4.3, 4.4 | 4.3, 4.3 | 3.9, 4.7 | 4.0, 4.7 |
| Sodium (mEq/L) | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 139.6 | 139.5 | 139.2 | 139.0 | 141.2 | 140.1 |
| SD, SEM | 2.9, 0.1 | 2.8, 0.1 | 3.5, 0.2 | 3.2, 0.1 | 2.6, 1.0 | 2.4, 0.7 |
| Mean 95% CI | 139.4, 139.8 | 139.3, 139.6 | 138.7, 139.6 | 138.7, 139.3 | 138.5, 143.9 | 138.6, 141.6 |
| Bicarbonate (mEq/L) | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 25.4 | 25.2 | 24.6 | 24.6 | 24.3 | 24.8 |
| SD, SEM | 3.5, 0.1 | 3.4, 0.1 | 3.4, 0.2 | 3.3, 0.1 | 4.2, 1.7 | 3.1, 0.9 |
| Mean 95% CI | 25.1, 25.7 | 25.0, 25.4 | 24.2, 25.0 | 24.3, 24.8 | 19.9, 28.6 | 22.8, 26.7 |
| Chloride (mEq/L) | ||||||
| n | 637 | 1,344 | 233 | 496 | 6 | 12 |
| Mean | 103.7 | 103.8 | 103.2 | 103.0 | 105.5 | 104.8 |
| SD, SEM | 2.9, 0.1 | 3.2, 0.1 | 3.2, 0.2 | 3.5, 0.2 | 3.0, 1.2 | 3.6, 1.1 |
| Mean 95% CI | 103.5, 103.9 | 103.6, 103.9 | 102.8, 103.6 | 102.7, 103.3 | 102.3, 108.7 | 102.4, 107.1 |
a
Excludes patients with renal dysfunction at baseline.
BUN, blood urea nitrogen; CI, confidence interval; eGFR, estimated glomerular filtration rate; SD, standard deviation; SEM, standard error of the mean.