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. 2022 Dec;17(12):1763–1774. doi: 10.2215/CJN.02400222

Table 2.

Sensitivity analysis for primary and key secondary end points

Sensitivity Analysis Mean±SEM eGFR Change (ml/min per 1.73 m2) (95% Confidence Interval) P Value
Placebo (n=80) Bardoxolone Methyl (n=77) Difference between Treatment Groups
Year 2 primary end point (week 100 eGFR change)
 Control-based multiple imputation −8.5±1.5 (−11.4 to −5.6) −1.4±1.6 (−4.5 to 1.7) 7.1±2.1 (2.9 to 11.3) 0.001
 Tipping point analysis: bardoxolone week 100 shift=–22 ml/min per 1.73 m2 −8.5±1.7 (−11.7 to −5.3) −3.8±1.7 (−7.2 to −0.4) 4.7±2.4 (0.0 to 9.4) 0.05
Year 2 key secondary end point (week 104 eGFR change)
 Control-based multiple imputation −10.8±1.3 (−13.4 to −8.2) −7.8±1.4 (−10.6 to −5.0) 3.0±1.8 (−0.5 to 6.4) 0.09
Post hoc analysis using all available eGFR values collected approximately 104 weeks after randomization −10.4±1.3 (−13.0 to −7.9) −8.9±1.3 (−11.6 to −6.3) 1.5±1.7 (−1.9 to 4.9) 0.38
Post hoc imputation for patients progressing to kidney failure
  Week 104 eGFR=5 ml/min per  1.73 m2 −11.5±1.3 (−14.2 to −8.9) −7.1±1.5 (−10.1 to −4.1) 4.4±1.9 (0.7 to 8.2) 0.02
  Week 104 eGFR=0 ml/min per  1.73 m2 −11.8±1.4 (−14.5 to −9.1) −7.4±1.6 (−10.5 to −4.3) 4.4±2.0 (0.5 to 8.3) 0.03