Table 2.

Mean change from baseline to week 12 for primary and secondary outcomes

Outcome MeasuresPlaceboEsaxerenone 0.625 mg/dEsaxerenone 1.25 mg/dEsaxerenone 2.5 mg/dEsaxerenone 5 mg/d
UACR, mg/g Crn=73a; 66bn=71a; 68bn=72a; 65bn=70a; 66bn=72a; 58b
 Baseline, mean (SD)123 (58)117 (60)127 (69)125 (58)126 (62)
 Week 12, mean (SD)145 (191)113 (123)96 (110)81 (96)66 (63)
 Change from baseline, mean (SD)21 (181)−4 (97)−30 (104)−39 (83)−59 (65)
 Difference to baseline, geometric LS mean ratio [95% CI]c0.9 [0.8 to 1.1]0.8 [0.7 to 0.9]0.6 [0.5 to 0.7]0.5 [0.4 to 0.6]0.4 [0.4 to 0.5]
 Difference to placebo, geometric LS mean ratio [95% CI]c0.8 [0.7 to 1.0]0.7 [0.5 to 0.8]0.5 [0.4 to 0.7]0.5 [0.4 to 0.6]
 UACR remission rate, n (%)2 (3)5 (8)8 (12)14 (21)12 (21)
 Treatment difference, OR [95% CI]d2.2 [0.4 to 12]4.4 [0.9 to 22]10 [2.1 to 49]10 [2.1 to 50]
eGFR, ml/min per 1.73 m2n=73a; 67bn=71a; 68bn=72a; 65bn=70a; 66bn=72a; 58b
 Baseline, mean (SD)69 (18)65 (14)66 (18)68 (19)69 (18)
 Week 12, mean (SD)71 (21)66 (15)64 (23)66 (22)65 (19)
 Change from baseline, mean (SD)1 (6)0.3 (7)−2 (8)−2 (8)−6 (8)
 Difference to baseline, LS mean [95% CI]e1 [−0.5 to 3.0]0.4 [−1.3 to 2.2]−2 [−3.5 to 0.1]−2 [−3.5 to 0.1]−7 [−8.6 to −4.8]
 Difference to placebo, LS mean [95% CI]e−0.8 [−3.3 to 1.7]−3 [−5.5 to −0.5]−3 [−5.5 to −0.5]−8 [−10 to −5.3]
Serum K+, mEq/Ln=72a; 66bn=71a; 68bn=72a; 65bn=70a; 66bn=73a; 59b
 Baseline, mean (SD)4.3 (0.3)4.2 (0.3)4.3 (0.3)4.3 (0.3)4.2 (0.3)
 Week 12, mean (SD)4.2 (0.3)4.3 (0.4)4.4 (0.5)4.4 (0.4)4.6 (0.5)
 Change from baseline, mean (SD)−0.1 (0.3)0.1 (0.3)0.1 (0.4)0.1 (0.4)0.4 (0.4)
 Difference to placebo [95% CI]0.2 [0.1 to 0.3]0.3 [0.1 to 0.4]0.2 [0.1 to 0.4]0.5 [0.4 to 0.6]
  • UACR, urinary albumin-to-creatinine ratio; Cr, creatinine; LS, least squares; 95% CI, 95% confidence interval; —, not applicable; OR, odds ratio; K+, potassium.

  • a Number of participants at baseline.

  • b Number of participants at week 12.

  • c On the basis of the analysis of covariance model, with treatment group as a factor and log-transformed baseline values of eGFR and sitting systolic BP as covariates. Estimates are back transformed and expressed as the ratio in the original scale.

  • d Adjusted for baseline UACR, eGFR, and sitting systolic BP.

  • e Adjusted for baseline eGFR.