Table 3.

Change in eGFR (ml/min per 1.73 m2) and in ACR (mg/mmol)

TimeAvosentan 25 mg (n = 455)Avosentan 50 mg (n = 478)Placebo (n = 459)P
Avosentan 25 mg versus PlaceboAvosentan 50 mg versus Placebo
eGFR ml/min
    baseline
        n455478459
        mean ± SD33.8 ± 11.233.2 ± 10.933.0 ± 10.6
    3 months
        n303330345
        mean ± SD31.7 ± 11.530.4 ± 11.630.9 ± 10.5
        change from baseline (mean ± SD)−1.66 ± 6.01−2.71 ± 7.03−1.70 ± 5.870.932a0.030a
    6 months
        n192200236
        mean ± SD29.5 ± 10.029.3 ± 11.430.0 ± 11.7
        change from baseline (mean ± SD)−3.35 ± 6.18−4.08 ± 6.94−2.50 ± 6.870.184a0.018a
ACR (mg/mmol)
    baseline
        n455478459
        median160.9166.5173.2
        IQR82.5 to 274.485.8 to 284.589.9 to 319.5
    3 months
        n294308334
    median100.3105.3166.7
        IQR40.7 to 198.342.8 to 219.868.0 to 328.6
        % median change−40.50−38.30−7.66<0.001b<0.001b
        IQR−60.70 to −10.40−62.50 to −1.38−32.60 to 21.30
    6 months
        n194199234
    median89.289.4164.8
        IQR28.9 to 200.232.2 to 182.365.5 to 283.5
        % median change−44.30−49.30−9.69<0.001b<0.001b
        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.