Table 1. Baseline characteristics by eGFR and uACR.
| eGFR (mL/min/1.73m2) | uACR (mg/g) | |||||||
|---|---|---|---|---|---|---|---|---|
| <30 (n=2282) |
≥30 to
<45 (n=2928) |
≥45 (n=1399) |
<30 (n=1328) |
≥30 to
≤300 (n=1864) |
>300 (n=3417) |
|||
| Demographics | ||||||||
| Age at randomization (years) | 65 (13) | 64 (13) | 58 (15) | 71 (9) | 66 (13) | 59 (14) | ||
| Sex | ||||||||
| Men | 1533 (67%) | 1937 (66%) | 947 (68%) | 725 (55%) | 1268 (68%) | 2424 (71%) | ||
| Women | 749 (33%) | 991 (34%) | 452 (32%) | 603 (45%) | 596 (32%) | 993 (29%) | ||
| Race | ||||||||
| White | 1440 (63%) | 1833 (63%) | 586 (42%) | 1069 (80%) | 1189 (64%) | 1601 (47%) | ||
| Black | 98 (4%) | 119 (4%) | 45 (3%) | 71 (5%) | 89 (5%) | 102 (3%) | ||
| Asian | 707 (31%) | 930 (32%) | 756 (54%) | 173 (13%) | 562 (30%) | 1658 (49%) | ||
| Mixed | 6 (0%) | 13 (0%) | 2 (0%) | 2 (0%) | 6 (0%) | 13 (0%) | ||
| Other | 31 (1%) | 33 (1%) | 10 (1%) | 13 (1%) | 18 (1%) | 43 (1%) | ||
| Prior disease | ||||||||
| Prior diabetes* | 1151 (50%) | 1371 (47%) | 518 (37%) | 647 (49%) | 943 (51%) | 1450 (42%) | ||
| Prior diabetes type | ||||||||
| Type 1 | 31 (1%) | 28 (1%) | 9 (1%) | 11 (1%) | 20 (1%) | 37 (1%) | ||
| Type 2 | 1106 (48%) | 1333 (46%) | 497 (36%) | 633 (48%) | 916 (49%) | 1387 (41%) | ||
| Other/unknown | 14 (1%) | 10 (0%) | 12 (1%) | 3 (0%) | 7 (0%) | 26 (1%) | ||
| History of cardiovascular disease§ | 718 (31%) | 828 (28%) | 219 (16%) | 484 (36%) | 579 (31%) | 702 (21%) | ||
| Clinical measurements | ||||||||
| Systolic blood pressure (mmHg) | 137.6 (18.6) | 136.0 (18.2) | 135.9 (17.8) | 130.8 (18.0) | 134.3 (17.7) | 139.9 (18.0) | ||
| Diastolic blood pressure (mmHg) | 76.5 (11.8) | 77.9 (11.7) | 80.9 (11.6) | 73.5 (10.7) | 75.8 (11.6) | 81.0 (11.5) | ||
| Body mass index (kg/m2) | 30.1 (6.7) | 30.1 (6.9) | 28.5 (6.5) | 31.5 (7.1) | 29.9 (6.6) | 29.0 (6.6) | ||
| Laboratory measurements | ||||||||
| eGFR (mL/min/1.73m2)† | ||||||||
| Mean (SD) | 24.6 (3.6) | 36.8 (4.2) | 59.3 (13.5) | 35.1 (8.2) | 36.3 (12.8) | 38.7 (16.8) | ||
| <30 | 2282 (100%) | 0 (0%) | 0 (0%) | 386 (29%) | 639 (34%) | 1257 (37%) | ||
| ≥30 to <45 | 0 (0%) | 2928 (100%) | 0 (0%) | 789 (59%) | 896 (48%) | 1243 (36%) | ||
| ≥45 | 0 (0%) | 0 (0%) | 1399 (100%) | 153 (12%) | 329 (18%) | 917 (27%) | ||
| uACR (mg/g)† | ||||||||
| Median (Q1,Q3) | 410 (59-1373) | 187 (26-781) | 515 (214-1199) | 7 (6-18) | 117 (59-202) | 1033 (575-1910) | ||
| <30 | 386 (17%) | 789 (27%) | 153 (11%) | 1328 (100%) | 0 (0%) | 0 (0%) | ||
| ≥30 to ≤300 | 639 (28%) | 896 (31%) | 329 (24%) | 0 (0%) | 1864 (100%) | 0 (0%) | ||
| >300 | 1257 (55%) | 1243 (42%) | 917 (66%) | 0 (0%) | 0 (0%) | 3417 (100%) | ||
| NT-proBNP (ng/L) | 713 (1681) | 470 (1091) | 211 (476) | 506 (930) | 535 (1220) | 477 (1384) | ||
| Glycated haemoglobin (mmol/mol) | 45.5 (13.7) | 45.5 (13.7) | 43.1 (13.1) | 45.5 (12.1) | 45.8 (13.4) | 44.3 (14.2) | ||
| Glycated haemoglobin (%) | 6.3 (1.3) | 6.3 (1.3) | 6.1 (1.2) | 6.3 (1.1) | 6.3 (1.2) | 6.2 (1.3) | ||
| Concomitant medication use | ||||||||
| RAS inhibitor | 1872 (82%) | 2487 (85%) | 1269 (91%) | 1073 (81%) | 1545 (83%) | 3010 (88%) | ||
| Any diuretic | 1151 (50%) | 1271 (43%) | 393 (28%) | 777 (59%) | 868 (47%) | 1170 (34%) | ||
| Any lipid-lowering medication | 1657 (73%) | 1955 (67%) | 766 (55%) | 992 (75%) | 1274 (68%) | 2112 (62%) | ||
| Cause of kidney disease | ||||||||
| Diabetic kidney disease | 801 (35%) | 901 (31%) | 355 (25%) | 376 (28%) | 623 (33%) | 1058 (31%) | ||
| Hypertensive/renovascular disease | 533 (23%) | 699 (24%) | 213 (15%) | 469 (35%) | 444 (24%) | 532 (16%) | ||
| Glomerular disease | 452 (20%) | 636 (22%) | 581 (42%) | 66 (5%) | 344 (18%) | 1259 (37%) | ||
| Other/unknown | 496 (22%) | 692 (24%) | 250 (18%) | 417 (31%) | 453 (24%) | 568 (17%) | ||
Figures are n (%), mean (SD) or median (Q1, Q3). NT-proBNP=N-terminal pro B-type natriuretic peptide. eGFR=estimated glomerular filtration rate. uACR=urinary albumin-to-creatinine ratio. RAS=renin-angiotensin system.
*
Prior diabetes mellitus defined as diabetes at randomization is defined as participant-reported history of diabetes of any type, use of glucose-lowering medication or baseline HbA1c ≥48 mmol/mol at Randomization visit.
§
Defined as self-reported history of myocardial infarction, heart failure, stroke, transient ischemic attack, or peripheral arterial disease.
†
Uses central measurement taken at the randomization visit, or more recent local laboratory result before randomization.