28 July 2020: Original Paper
Effect of Concentration/Dose Ratio in Kidney Transplant Recipients Receiving LCP-Tacrolimus or Immediate-Release Tacrolimus: Post Hoc Analysis of a Phase 3 Clinical Trial
Barbara Suwelack 1ABDE* , Suphamai Bunnapradist 2BDE , Ulf Meier-Kriesche 3ACDE , Daniel R. Stevens 3ACDE , Claudio Procaccianti 4ACDE , Roberto Morganti 4ACDE , Klemens Budde 5ACDEDOI: 10.12659/AOT.923278
Ann Transplant 2020; 25:e923278
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) | |
| 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 IR-Tac) | 0.3417 | 0.2134 | 0.2240 | 0.2497 | ||||
| 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 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. | ||||||||