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 |