Table 1.
Baseline characteristics by 6-week change in eGFR tertile for both randomized treatments
| Tertile (change in eGFR from baseline at week 6; mL/min per 1.73 m2) | Ertugliflozin |
Placebo |
||||
|---|---|---|---|---|---|---|
| Tertile 1 (change in eGFR >+1.00) | Tertile 2 (change in eGFR >−5.99 and ≤+1.00) | Tertile 3 (change in eGFR of ≤–6.00) | Tertile 1 (change in eGFR >+1.00) | Tertile 2 (change in eGFR >−5.99 and ≤+1.00) | Tertile 3 (change in eGFR of ≤–6.00) | |
| N (%) | 1,503 (28.4) | 1,655 (31.2) | 2,141 (40.4) | 1,076 (40.9) | 861 (32.8) | 691 (26.3) |
| LSM in eGFR from baseline at week 6, mL/min per 1.73 m2 (95% CI) | 8.69 (8.38, 9.00) | −2.17 (−2.47,–1.88) | −12.46 (−12.72,–12.20) | 8.55 (8.18,8.92) | −1.91 (−2.32,–1.50) | −12.49 (−12.95,–12.03) |
| Female, n (%) | 461 (30.7) | 472 (28.5) | 627 (29.3) | 319 (29.6) | 262 (30.4) | 219 (31.7) |
| Age, years | 63.7 (8.0) | 64.9 (8.1) | 64.3 (8.1) | 64.2 (8.2) | 65.2 (7.6) | 63.5 (8.1) |
| Duration of DM, years | 12.5 (8.3) | 12.8 (8.1) | 13.1 (8.2) | 13.4 (8.5) | 13.4 (8.3) | 12.3 (8.1) |
| HbA1c, % | 8.3 (1.0) | 8.2 (0.9) | 8.2 (1.0) | 8.3 (1.0) | 8.2 (0.9) | 8.2 (0.9) |
| Body weight, kg | 90.9 (17.8) | 91.2 (17.7) | 92.8 (19.5) | 91.4 (17.5) | 93.3 (19.3) | 91.0 (17.8) |
| Body mass index, kg/m2 | 31.8 (5.2) | 31.7 (5.1) | 32.2 (5.6) | 31.8 (5.4) | 32.5 (5.6) | 31.5 (5.3) |
| Median UACR, mg/g (IQR) | 17.0 (6.0–59.0) | 18.0 (6.0–68.0) | 20.0 (7.0–78.5) | 21.0 (6.0–66.5) | 19.0 (6.0–71.0) | 17.0 (7.0–63.0) |
| SBP, mm Hg | 131.9 (13.5) | 133.3 (13.6) | 134.6 (13.6) | 132.3 (14.0) | 133.4 (13.9) | 133.6 (13.6) |
| Hematocrit, % | 43.6 (4.2) | 43.1 (4.1) | 42.7 (4.0) | 43.1 (4.0) | 42.7 (4.3) | 42.9 (4.0) |
| eGFR, mL/min per 1.73 m2 | 74.2 (19.2) | 71.3 (20.0) | 81.1 (21.5) | 72.4 (19.7) | 71.7 (18.7) | 86.2 (21.3) |
| Serum uric acid, mg/dL | 5.6 (1.6) | 5.7 (1.6) | 5.6 (1.5) | 5.8 (1.7) | 5.8 (1.6) | 5.4 (1.5) |
| Serum albumin, mg/dL | 4.5 (0.3) | 4.4 (0.3) | 4.4 (0.3) | 4.4 (0.3) | 4.4 (0.3) | 4.4 (0.3) |
| CKD stage 3 (eGFR <60 mL/min per 1.73 m2), n (%) | 335 (22.3) | 487 (29.4) | 332 (15.5) | 279 (25.9) | 235 (27.3) | 66 (9.6) |
| CKD stage 2 (eGFR ≥60 and <90 mL/min per 1.73 m2), n (%) | 863 (57.4) | 867 (52.4) | 1,096 (51.2) | 587 (54.6) | 470 (54.6) | 337 (48.8) |
| CKD stage 1 (eGFR ≥90 mL/min per 1.73 m2), n (%) | 305 (20.3) | 301 (18.2) | 713 (33.3) | 210 (19.5) | 156 (18.1) | 288 (41.7) |
| Normoalbuminuria (UACR <30 mg/g), n (%) | 900 (61.3) | 960 (59.7) | 1,209 (58.1) | 623 (59.2) | 499 (59.1) | 407 (60.5) |
| Elevated albuminuria (UACR ≥30 mg/g), n (%) | 568 (38.7) | 649 (40.3) | 871 (41.9) | 429 (40.8) | 346 (40.9) | 266 (39.5) |
| KDIGO low risk,a n (%) [20] | 720 (49.0) | 732 (45.4) | 1,066 (51.3) | 472 (45.0) | 396 (46.8) | 383 (56.9) |
| KDIGO moderate risk,b n (%) [20] | 488 (33.2) | 501 (31.1) | 657 (31.6) | 358 (34.1) | 263 (31.1) | 207 (30.8) |
| KDIGO high/very high risk, c n (%) [20] | 261 (17.8) | 378 (23.5) | 357 (17.2) | 220 (21.0) | 187 (22.1) | 83 (12.3) |
| Insulin use, n (%) | 636 (42.3) | 813 (49.1) | 1,013 (47.3) | 529 (49.2) | 440 (51.1) | 311 (45.0) |
| Metformin use, n (%) | 1,172 (78.0) | 1,209 (73.1) | 1,652 (77.2) | 842 (78.3) | 658 (76.4) | 541 (78.3) |
| RAAS inhibitor use, n (%) | 1,192 (79.3) | 1,343 (81.1) | 1,757 (82.1) | 879 (81.7) | 707 (82.1) | 558 (80.8) |
| Diuretic use, n (%) | 616 (41.0) | 692 (41.8) | 956 (44.7) | 459 (42.7) | 391 (45.4) | 292 (42.3) |
Data are mean (standard deviation) unless otherwise specified. CI, confidence interval; CKD, chronic kidney disease; DM, diabetes mellitus; eGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; IQR, interquartile range; KDIGO CKD, Kidney Disease: Improving Global Outcomes in Chronic Kidney Disease; LSM, least squares mean; RAAS, renin-angiotensin-aldosterone system; SBP, systolic blood pressure; UACR, urinary albumin-to-creatinine ratio.
Baseline eGFR ≥60 mL/min per 1.73 m2 and UACR <30 mg/g.
Baseline eGFR ≥60 mL/min per 1.73 m2 and UACR ≥30 and ≤300 mg/g or if baseline eGFR ≥45 and <60 mL/min per 1.73 m2 and UACR <30 mg/g.
Baseline eGFR ≥60 mL/min per 1.73 m2 and UACR >300 mg/g or if baseline eGFR ≥45 and <60 mL/min per 1.73 m2 and UACR >30 mg/g or if baseline eGFR <45 mL/min per 1.73 m2.