Table 2.
Slope of eGFR change over months 6–24.
| Statistic | LCPT | IR-Tac | ||||||
|---|---|---|---|---|---|---|---|---|
| Overall (n=218) | Rapid metabolizers (n=68) | Intermediate metabolizers (n=78) | Slow metabolizers (n=72) | Overall (n=223) | Rapid metabolizers (n=71) | Intermediate metabolizers (n=79) | Slow metabolizers (n=73) | |
| Slope of change in eGFR, observed (mL/min/1.73 m2 per day) | ||||||||
| LS mean (95% CI) | 0.136 (0.022, 0.249) | 0.315 (0.154, 0.477) | 0.098 (−0.120, 0.316) | 0.007 (−0.192, 0.206) | 0.213 (0.101, 0.325) | 0.172 (0.014, 0.331) | 0.288 (0.071, 0.505) | 0.171 (−0.027, 0.368) |
| Difference (95% CI) | −0.077 (−0.237, 0.082) | 0.143 (−0.083, 0.369) | −0.190 (−0.498, 0.117) | −0.164 (−0.444, 0.116) | ||||
| P-value (LCPT vs. IR-Tac) | 0.3417 | 0.2134 | 0.2240 | 0.2497 | ||||
| Slope of change in eGFR, change from baseline (mL/min/1.73 m2 per day) | ||||||||
| LS mean (95% CI) | 0.037 (−0.109, 0.183) | 0.348 (0.176, 0.521) | −0.071 (−0.340, 0.198) | −0.140 (−0.432, 0.152) | 0.138 (−0.007, 0.282) | 0.082 (−0.086, 0.251) | 0.273 (0.006, 0.540) | 0.044 (−0.246, 0.334) |
| Difference (95% CI) | −0.101 (−0.306, 0.105) | 0.266 (0.024, 0.508) | −0.344 (−0.723, 0.035) | −0.184 (−0.596, 0.228) | ||||
| P-value (LCPT vs. IR-Tac) | 0.3362 | 0.0314 | 0.0750 | 0.3789 | ||||
Analysis population consisted of patients who had a calculable day 30 C/D ratio based on central or local laboratory data. N represents patients with analyzable data for this endpoint. Treatment effect on the rate of eGFR change over time was assessed with an analysis of covariance model with main effect of treatment and baseline eGFR as covariates within overall and each metabolizer subgroup. C/D – concentration/dose; CI – confidence interval; eGFR – estimated glomerular filtration rate; IR-Tac – immediate-release tacrolimus; LCPT – LCP-tacrolimus; LS – least squares.