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
Supplementary Table 2 Sensitivity analyses for eGFR (mL/min/1.73 m2) at months 1–24.
| Analysis | Statistics | LCPT | IR-Tac | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall (N=247) | Rapid metabolizers (N=82) | Intermediate metabolizers (N=83) | Slow metabolizers (N=82) | Overall (N=249) | Rapid metabolizers (N=82) | Intermediate metabolizers (N=85) | Slow metabolizers (N=82) | ||
| Model 2 | LS mean (95% CI) | 57.738 (55.353, 60.123) | 57.521 (53.439, 61.604) | 56.814 (52.951, 60.676) | 58.737 (54.334, 63.140) | 59.002 (56.646, 61.359) | 53.693 (49.710, 57.675) | 60.208 (56.364, 64.052) | 62.798 (58.423, 67.173) |
| Difference (95% CI) | −1.264 (−4.617, 2.088) | 3.829 (−1.875, 9.532) | −3.394 (−8.843, 2.056) | −4.061 (−10.268, 2.146) | – | – | – | – | |
| -value: treatment | 0.4590 | 0.1866 | 0.2205 | 0.1980 | – | – | – | – | |
| Model 3 | LS mean (95% CI) | 57.516 (55.145, 59.887) | 56.075 (52.105, 60.046) | 56.971 (53.193, 60.749) | 58.192 (53.881, 62.502) | 58.575 (56.232, 60.917) | 53.262 (49.392, 57.132) | 59.552 (55.794, 63.310) | 62.488 (58.209, 66.768) |
| Difference (95% CI) | −1.058 (−4.392, 2.275) | 2.814 (−2.731, 8.358) | −2.581 (−7.910, 2.748) | −4.297 (−10.371, 1.777) | – | – | – | – | |
| -value: treatment | 0.8914 | 0.7945 | 0.8487 | 0.4078 | – | – | – | – | |
| Model 4 | LS mean (95% CI) | 57.722 (55.291, 60.154) | 57.338 (53.136, 61.540) | 56.907 (52.969, 60.845) | 59.018 (54.583, 63.453) | 58.927 (56.525, 61.329) | 53.681 (49.576, 57.785) | 60.001 (56.086, 63.916) | 62.861 (58.459, 67.263) |
| Difference (95% CI) | −1.205 (−4.623, 2.213) | 3.657 (−2.217, 9.531) | −3.095 (−8.648, 2.459) | −3.844 (−10.093, 2.405) | – | – | – | – | |
| -value: treatment | 0.8149 | 0.5097 | 0.7598 | 0.4590 | – | – | – | – | |
| Model 5 | LS mean (95% CI) | 57.666 (55.248, 60.083) | – | – | – | 58.898 (56.510, 61.286) | – | – | – |
| Difference (95% CI) | −1.232 (−4.628, 2.164) | – | – | – | – | – | – | – | |
| -value: treatment | 0.8017 | – | – | – | – | – | – | – | |
| Model 6 | LS mean (95% CI) | 57.575 (55.144, 60.007) | – | – | – | 59.069 (56.667, 61.472) | – | – | – |
| Difference (95% CI) | −1.494 (−4.920, 1.931) | – | – | – | – | – | – | – | |
| -value: treatment | 0.6891 | – | – | – | – | – | – | – | |
| Analysis population consisted of patients who had a calculable day 30 C/D ratio based on central or local laboratory data. Model 2: general linear model for repeated measures with time as categorical variable. Model 3: general linear model for repeated measures with time as quantitative variable. Model 4: general linear model for repeated measures with random intercept and time. Model 5: C/D group included as a covariate. Model 6: CD/ratio included as a covariate. C/D – concentration/dose; CI – confidence interval; eGFR – estimated glomerular filtration rate; IR-Tac – immediate-release tacrolimus; LCPT – LCP-tacrolimus; LS – least squares. | |||||||||