Table 1.
Clinical, laboratory, and genetic characteristics at baseline, by image-based classification and treatment group
| Class | 1 |
2 |
Total | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All | B | C | D | E | All | A − Ba | |||||||
| Treatment group | TLV | PLC | TLV | PLC | TLV | PLC | TLV | PLC | TLV | PLC | |||
| Patient number | 1391 | 75 | 31 | 340 | 191 | 332 | 161 | 179 | 82 | 45 | 28 | 17 | 1436 |
| Male, n (%) | 730 (53) | 25 (33) | 12 (39) | 158 (47) | 94 (49) | 189 (57) | 84 (52) | 110 (62) | 58 (71) | 12 (27) | 9 (32) | 3 (18) | 742 (52) |
| Age, yr | 39 | 45 | 45 | 41 | 42 | 38 | 38 | 33 | 31 | 41 | 42 | 42 | 39 |
| Patients w/HTN, n (%) | 1158 (83.2) | 58 (77) | 26 (84) | 269 (79) | 147 (77) | 279 (84) | 145 (90) | 159 (89) | 75 (91) | 27 (60) | 17 (61) | 10 (59) | 1185 (82.5) |
| SBP (mm Hg) | 129 | 127 | 129 | 128 | 127 | 129 | 130 | 130 | 129 | 125 | 127 | 123 | 129 |
| DBP (mm Hg) | 83 | 80 | 83 | 82 | 82 | 83 | 83 | 84 | 83 | 80 | 81 | 80 | 82 |
| eGFR, ml/min/1.73 m2 | 81.3 | 81.5 | 82.4 | 82.3 | 82.8 | 79.8 | 80.5 | 81.6 | 80.5 | 90.1 | 85.8 | 97.3 | 81.6 |
| HtTKV, ml/m | 971 | 509 | 507 | 710 | 732 | 1060 | 1039 | 1513 | 1536 | 909 | 979 | 794 | 969 |
| Genetic analysis, n (%) | 745 (53.6) | 39 (52) | 21 (67.7) | 177 (52.1) | 114 (59.7) | 178 (53.6) | 93 (57.8) | 78 (43,6) | 45 (54.9) | 22 (48.9) | 10 (35.7) | 12 (70.6) | 767 (53.4) |
| NMD, n (%)b | 15 (2.0) | 2 (5.1) | 0 (0) | 4 (2.3) | 3 (2.6) | 2 (1.1) | 0 (0) | 3 (3.8) | 1 (2.2) | 4 (18.2) | 1 (10) | 3 (25) | 19 (2.5) |
| PKD1, n (%)b | 646 (86.7) | 32 (82) | 15 (71.4) | 151 (85.3) | 92 (80.7) | 156 (87.6) | 86 (92.5) | 73 (93.6) | 41 (91.1) | 9 (40.9) | 5 (50) | 4 (33.3) | 655 (85.4) |
| PKD2, n (%)b | 82 (11.3) | 5 (12.8) | 6 (28.6) | 22 (12.4) | 19 (16.7) | 20 (11.2) | 7 (7.5) | 2 (2.6) | 3 (6.7) | 9 (40.9) | 4 (40) | 5 (41.7) | 93 (12.1) |
DBP, diastolic blood pressure, average during clinical trial; eGFR, estimated glomerular filtration rate (estimated by CKD-EPI equation); HTN, patients with a diagnosis of hypertension at baseline; HtTKV, height adjusted total kidney volume; NMD, no mutation detected; PLC, placebo treatment group; SBP, systolic blood pressure, average during clinical trial; TLV, tolvaptan treatment group.
a
Only 1 patient was classified as class 2B.
b
Percent frequencies of mutations in the patients who had genetic analysis.