Table 1.
Summary of Demographics and Baseline Characteristics
| Part 1 | Part 2 | ||||
|---|---|---|---|---|---|
| Normal Renal Function | Moderate Renal Impairment | Severe/ESRD Not on Hemodialysis | Total | ESRD on Hemodialysis | |
| Number of Subjects | (N = 8) | (N = 8) | (N = 8) | (N = 24) | (N = 8) |
| Completed, n (%) | 8 (100.0) | 8 (100.0) | 8 (100.0) | 24 (100.0) | 8 (100.0) |
| Withdrawn, n (%) | 0 | 0 | 0 | 0 | 0 |
| Demographics/baseline characteristics | |||||
| Age (y), mean (SD) | 61.5 (10.78) | 72.0 (7.05) | 61.4 (12.49) | 65.0 (11.13) | 51.8 (7.09) |
| Age ranges, n (%) | |||||
| Adult 18‐64 y | 4 (50.0) | 1 (12.5) | 4 (50.0) | 9 (37.5) | 8 (100.0) |
| ≥65‐84 y | 4 (50.0) | 7 (87.5) | 4 (50.0) | 15 (62.5) | 0 |
| Sex, n (%) | |||||
| Female | 3 (37.5) | 1 (12.5) | 4 (50.0) | 8 (33.3) | 1 (12.5) |
| Male | 5 (62.5) | 7 (87.5) | 4 (50.0) | 16 (66.7) | 7 (87.5) |
| BMI (kg/m2), mean (SD) | 29.50 (3.929) | 27.74 (4.383) | 30.46 (6.175) | 29.23 (4.846) | 29.61 (4.786) |
| Height (cm), mean (SD) | 169.85 (7.235) | 169.76 (6.856) | 165.31 (9.741) | 168.31 (7.987) | 177.96 (5.556) |
| Weight (kg), mean (SD) | 84.99 (10.669) | 79.99 (13.108) | 82.60 (14.493) | 82.53 (12.458) | 93.50 (13.968) |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 3 (37.5) | 4 (50.0) | 2 (25.0) | 9 (37.5) | 1 (12.5) |
| Not Hispanic or Latino | 5 (62.5) | 4 (50.0) | 6 (75.0) | 15 (62.5) | 7 (87.5) |
| Race detail, n (%) | |||||
| African American/African heritage | 1 (12.5) | 1 (12.5) | 2 (25.0) | 4 (16.7) | 8 (100.0) |
| American Indian or Alaska native | 0 | 1 (12.5) | 0 | 1 (4.2) | 0 |
| White, European heritage | 7 (87.5) | 6 (75.0) | 5 (62.5) | 18 (75.0) | 0 |
| Multiple | 0 | 0 | 1 (12.5) | 1 (4.2) | 0 |
| eGFR (mL/min per 1.73 m2), median (min, max) | 114.2 (94, 155) a | 43.3 (32, 54) | 16.5 (8, 26) | NA | 6.0 (4, 8) b |
| Childbearing potential, n (%) | |||||
| Postmenopausal | 2 (25.0) | 1 (12.5) | 4 (50.0) | 7 (29.2) | 0 |
| Sterile (of childbearing age) | 1 (12.5) | 0 | 0 | 1 (4.2) | 0 |
| Potentially able to bear children | 0 | 0 | 0 | 0 | 1 (12.5) |
| Cardiovascular‐related medical conditions, n (%) | |||||
| Any condition | 0 | 7 (87.5) | 8 (100.0) | 15 (62.5) | 8 (100.0) |
| Angina pectoris | 0 | 1 (12.5) | 0 | 1 (4.2) | 1 (12.5) |
| Diabetes mellitus | 0 | 5 (62.5) | 4 (50.0) | 9 (37.5) | 3 (37.5) |
| Hyperlipidemia | 0 | 4 (50.0) | 4 (50.0) | 8 (33.3) | 5 (62.5) |
| Hypertension | 0 | 7 (87.5) | 7 (87.5) | 14 (58.3) | 8 (100.0) |
| Myocardial Infarction | 0 | 0 | 0 | 0 | 1 (12.5) |
BMI indicates body mass index; eGFR, estimated glomerular filtration rate; ESRD, end‐stage renal disease.
a
n = 5.
b
n = 4.