Table 2.
Slope of TKV and eGFR from baseline to Month 24 in TEMPO 4:4
| Treatment Group | n | Slope (% per year) | Treatment difference | 95% CI | P-value | NI margin |
|---|---|---|---|---|---|---|
| TKV (mL) | ||||||
| Early-treateda | 509 | 6.16 | 1.01 | 1.00, 1.02 | 0.046 | 0.65 |
| Delayed-treateda | 268 | 4.96 | ||||
| eGFR, mL/min/1.73 m2b | ||||||
| Early-treateda | 548 | −3.26 | −0.11 | −0.75, 0.52 | 0.73 | 0.65 |
| Delayed-treateda | 304 | −3.14 | ||||
NI, non-inferiority.
a
The early-treatment group received tolvaptan in TEMPO 3:4 and the late-treatment group received placebo.
b
eGFR by CKD-EPI equation