Table 1. Baseline Characteristics of the Finerenone in Chronic Kidney Disease and Type 2 Diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial Programme Analysis (FIDELITY) Study Sample.
| Characteristica | eGFR <30 (n = 890) | eGFR 30-<45 (n = 3504) | eGFR 45-<60 (n = 3434) | eGFR 60-<90 (n = 3876) | eGFR ≥90 (n = 1319) | UACR <300 mg/g (n = 4329) | UACR ≥300 mg/g (n = 8692) |
|---|---|---|---|---|---|---|---|
| Age, mean (SD), y | 66.9 (8.6) | 67.3 (9.0) | 66.5 (8.8) | 63.4 (9.1) | 56.0 (8.8) | 67.6 (8.6) | 63.3 (9.7) |
| Male sex, No. (%) | 570 (64.0) | 2399 (68.5) | 2468 (71.9) | 2768 (71.4) | 883 (66.9) | 3018 (69.7) | 6068 (69.8) |
| Female sex, No. (%) | 320 (36.0) | 1105 (31.5) | 966 (28.1) | 1108 (28.6) | 436 (33.1) | 1311 (30.3) | 2624 (30.2) |
| Race or ethnic group, No. (%) | |||||||
| Asian | 203 (22.8) | 811 (23.1) | 836 (24.3) | 856 (22.1) | 188 (14.3) | 821 (19.0) | 2073 (23.8) |
| Black/African American | 64 (7.2) | 147 (4.2) | 138 (4.0) | 134 (3.5) | 39 (3.0) | 159 (3.7) | 363 (4.2) |
| Hispanic | 132 (14.8) | 478 (13.6) | 504 (14.7) | 706 (18.2) | 277 (21.0) | 617 (14.3) | 1480 (17.0) |
| White | 561 (63.0) | 2358 (67.3) | 2286 (66.6) | 2645 (68.2) | 1018 (77.2) | 3162 (73.0) | 5704 (65.6) |
| Other/not reporteda | 62 (7.0) | 188 (5.4) | 174 (5.1) | 241 (6.2) | 74 (5.6) | 187 (4.3) | 552 (6.4) |
| Weight, mean (SD), kg | 86.4 (20.9) | 87.2 (19.7) | 87.2 (19.8) | 88.6 (19.8) | 92.4 (21.6) | 87.7 (19.6) | 88.3 (20.3) |
| Duration of diabetes, mean (SD), y | 17.5 (9.1) | 16.9 (9.1) | 15.7 (8.8) | 14.5 (8.2) | 11.8 (7.1) | 15.9 (9.1) | 15.1 (8.5) |
| HbA1c, mean (SD), % | 7.6 (1.3) | 7.6 (1.3) | 7.6 (1.3) | 7.7 (1.4) | 8.1 (1.5) | 7.6 (1.3) | 7.8 (1.4) |
| Systolic blood pressure, mean (SD), mm Hg | 136.0 (16.2) | 136.9 (14.7) | 136.6 (14.0) | 137.1 (13.9) | 136.1 (12.8) | 134.2 (14.4) | 138.0 (13.9) |
| Medical history, No. (%) | |||||||
| Cardiovascular disease | 448 (50.3) | 1856 (53.0) | 1746 (50.8) | 1505 (38.8) | 378 (28.7) | 2279 (52.6) | 3655 (42.1) |
| Baseline medications, No. (%) | |||||||
| Renin-angiotensin system inhibitors | 888 (99.8) | 3501 (>99.9) | 3424 (99.7) | 3868 (99.8) | 1319 (100.0) | 4321 (99.8) | 8677 (99.8) |
| Statins | 685 (77.0) | 2665 (76.1) | 2580 (75.1) | 2671 (68.9) | 796 (60.3) | 3237 (74.8) | 6159 (70.9) |
| Antiplatelets | 548 (61.6) | 2101 (60.0) | 2042 (59.5) | 2006 (51.8) | 604 (45.8) | 2588 (59.8) | 4711 (54.2) |
| Insulin | 614 (69.0) | 2185 (62.4) | 1963 (57.2) | 2131 (55.0) | 735 (55.7) | 2361 (54.5) | 5266 (60.6) |
| GLP-1 receptor agonists | 57 (6.4) | 245 (7.0) | 250 (7.3) | 290 (7.5) | 102 (7.7) | 330 (7.6) | 614 (7.1) |
| SGLT-2 inhibitors | 13 (1.5) | 129 (3.7) | 241 (7.0) | 344 (8.9) | 150 (11.4) | 299 (6.9) | 578 (6.6) |
| eGFR, mean (SD) | 26.9 (2.3) | 37.7 (4.3) | 52.0 (4.3) | 73.2 (8.6) | 99.7 (7.6) | 53.8 (18.3) | 59.5 (22.9) |
| eGFR, No. (%) | |||||||
| <30 | NA | NA | NA | NA | NA | 255 (5.9) | 635 (7.3) |
| 30-<45 | 1298 (30.0) | 2206 (25.4) | |||||
| 45-<60 | 1471 (34.0) | 1962 (22.6) | |||||
| 60-<90 | 1094 (25.3) | 2780 (32.0) | |||||
| ≥90 | 211 (4.9) | 1108 (12.7) | |||||
| UACR, median (IQR), mg/g | 720 (242-1642) | 516 (163-1250) | 389 (127-1009) | 546 (262-1100) | 604 (376-1103) | 114 (61-196) | 871 (513-1564) |
| UACR, No. (%), mg/g | |||||||
| <30 | 16 (1.8) | 68 (1.9) | 82 (2.4) | 51 (1.3) | 13 (1.0) | 230 (5.3) | 0 |
| 30-<300 | 239 (26.9) | 1230 (35.1) | 1389 (40.4) | 1043 (26.9) | 198 (15.0) | 4099 (94.7) | 0 |
| ≥300 | 635 (71.3) | 2206 (63.0) | 1962 (57.1) | 2780 (71.7) | 1108 (84.0) | 0 | 8692 (100.0) |
Abbreviations: eGFR, estimated glomerular filtration rate; GLP-1, glucagonlike peptide 1; HbA1c, hemoglobin A1c; NA, not applicable; SGLT-2, sodium-glucose cotransporter-2; UACR, urine albumin to creatinine ratio.
a
Other included American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, or those identifying as multiple races.