Table 1.
Demographics characteristics at TEMPO 3:4 and TEMPO 4:4 baseline
| Characteristics | TEMPO 3:4 |
TEMPO 4:4 |
||||
|---|---|---|---|---|---|---|
| Tolvaptan (n = 557) | Placebo (n = 314) | P-value | Early-treateda (n = 557) | Delayed-treateda (n = 314) | P-value | |
| Male, n (%) | 303 (54.4) | 159 (50.3) | 0.25 | |||
| Age, years [mean (SD)] | 38.9 (6.9) | 39.2 (7.3) | 0.30 | 42.2 (6.9) | 42.5 (7.2) | 0.32 |
| Race, n (%) | 0.55 | |||||
| Caucasian | 535 (96.1) | 302 (96.2) | ||||
| Black or African American | 9 (1.6) | 2 (0.6) | ||||
| Asian | 3 (0.5) | 2 (0.6) | ||||
| Other | 10 (1.8) | 8 (2.5) | ||||
| Height, cm [mean (SD)] | 174.6 (10.4) | 173.9 (9.8) | 0.32 | 174.8 (10.3) | 174.1 (9.7) | 0.35 |
| Weight, kg [mean (SD)] | 80.5 (17.7) | 79.2 (17.2) | 0.30 | 82.6 (18.4) | 81.0 (17.3) | 0.23 |
| Age at diagnosis, years [mean (SD)] | 27.1 (9.3) | 27.2 (9.6) | 0.76 | |||
| TKV, mL [median (IQR)] | 1498 (977) | 1468 (751) | 0.60 | 1706 (1199) | 1835 (1162) | 0.05 |
| TKV, % change from TEMPO 3:4 BL | 15.8 (17.0) | 23.8 (16.9) | <0.0001 | |||
| eGFR, mL/min/1.73 m2 [mean (SD)] | 82.2 (20.6) | 83.5 (22.6) | 0.59 | 72.3 (24.5) | 70.4 (25.0) | 0.38 |
| eGFR, change from TEMPO 3:4 BL [mean (SD)] | −8.1 (−10.3) | −10.6 (−13.71) | 0.003 | |||
| Blood pressure, mmHg (SD) | ||||||
| Diastolic | 82.6 (9.1) | 82.7 (9.0) | 0.92 | 80.8 (8.6) | 81.1 (8.8) | 0.41 |
| Systolic | 128.6 (13.2) | 128.8 (13.2) | 0.86 | 126.6 (12.4) | 127.0 (12.1) | 0.68 |
| ACE/ARB use, % (n) | 72.0 (401) | 71.0 (223) | 0.76 | 81.1 (452) | 78.7 (247) | 0.38 |
| ACR, mg/mmol (SD) | 6.41 (11.75) | 6.65 (16.31) | 0.85 | 6.07 (12.46) | 7.69 (19.27) | 0.04 |
| Copeptina, pmol/L (SD) | 8.7 (10.0) | 10.9 (25.5) | 0.70 | |||
| Days between TEMPO 3:4 and 4:4, days [mean, median (range)] | 81, 39 (13–566) | 80, 36 (13–829) | 0.84 | |||
Data are given as means with standard deviation (SD), or as median with interquartile range (IQR) when appropriate. BL, baseline.
a
The early-treatment group received tolvaptan in TEMPO 3:4 and the late-treatment group received placebo.