Time | Avosentan 25 mg (n = 455) | Avosentan 50 mg (n = 478) | Placebo (n = 459) | P | |
---|---|---|---|---|---|
Avosentan 25 mg versus Placebo | Avosentan 50 mg versus Placebo | ||||
eGFR ml/min | |||||
baseline | |||||
n | 455 | 478 | 459 | ||
mean ± SD | 33.8 ± 11.2 | 33.2 ± 10.9 | 33.0 ± 10.6 | ||
3 months | |||||
n | 303 | 330 | 345 | ||
mean ± SD | 31.7 ± 11.5 | 30.4 ± 11.6 | 30.9 ± 10.5 | ||
change from baseline (mean ± SD) | −1.66 ± 6.01 | −2.71 ± 7.03 | −1.70 ± 5.87 | 0.932^{a} | 0.030^{a} |
6 months | |||||
n | 192 | 200 | 236 | ||
mean ± SD | 29.5 ± 10.0 | 29.3 ± 11.4 | 30.0 ± 11.7 | ||
change from baseline (mean ± SD) | −3.35 ± 6.18 | −4.08 ± 6.94 | −2.50 ± 6.87 | 0.184^{a} | 0.018^{a} |
ACR (mg/mmol) | |||||
baseline | |||||
n | 455 | 478 | 459 | ||
median | 160.9 | 166.5 | 173.2 | ||
IQR | 82.5 to 274.4 | 85.8 to 284.5 | 89.9 to 319.5 | ||
3 months | |||||
n | 294 | 308 | 334 | ||
median | 100.3 | 105.3 | 166.7 | ||
IQR | 40.7 to 198.3 | 42.8 to 219.8 | 68.0 to 328.6 | ||
% median change | −40.50 | −38.30 | −7.66 | <0.001^{b} | <0.001^{b} |
IQR | −60.70 to −10.40 | −62.50 to −1.38 | −32.60 to 21.30 | ||
6 months | |||||
n | 194 | 199 | 234 | ||
median | 89.2 | 89.4 | 164.8 | ||
IQR | 28.9 to 200.2 | 32.2 to 182.3 | 65.5 to 283.5 | ||
% median change | −44.30 | −49.30 | −9.69 | <0.001^{b} | <0.001^{b} |
IQR | −71.4 to −6.5 | −72.8 to −17.5 | −41.4 to 31.0 |
All parameters were measured in a central laboratory, eGFR was calculated with the six-item MDRD formula. For each ACR value, the geometric mean of three consecutive first morning urine values was entered into the database. With repeated measures ANOVA, changes of ACR were significant at P < 0.001 for both dosages; changes of eGFR were significant for the 50-mg dosage versus placebo (P = 0.0238) but not for the 25-mg dosage (P = 0.5160).
↵^{a} One-way ANOVA from summary data.
↵^{b} Wilcoxon test.