Renal endpoints in the extension study population
| CNI-free (n = 41) | CNI (n = 40) | Difference [95% CI] | p-Value | |
|---|---|---|---|---|
| Randomization | ||||
| eGFR, Cockcroft-Gault (mL/min) | 81.8 (23.6) | 81.2 (24.1) | – | 0.909 |
| eGFR, Nankivell (mL/min/1.73 m2) | 92.0 (20.5) | 89.2 (20.1) | – | 0.535 |
| eGFR, MDRD4 (mL/min/1.73 m2) | 79.0 (23.5) | 77.8 (24.4) | – | 0.814 |
| Month 11 postrandomization | ||||
| eGFR, Cockcroft-Gault (mL/min) | ||||
| Unadjusted | 88.2 (29.0) | 81.4 (22.1) | – | 0.240 |
| Adjusted | 88.2 [79.4; 97.0] | 82.0 [72.3; 91.8] | 6.2 [−4.2; 16.6] | 0.236 |
| Adjusted change from randomization | 6.8 [−2.1; 15.6] | 0.5 [−9.2; 10.3] | – | – |
| eGFR, Nankivell (mL/min/1.73 m2) | ||||
| Unadjusted | 92.5 (18.3) | 85.9 (15.5) | – | 0.084 |
| Adjusted | 92.6 [86.4; 98.8] | 87.8 [81.0; 94.6] | 4.8 [−2.4; 12.1] | 0.189 |
| Adjusted change from randomization | 2.0 [−4.2; 8.2] | −2.8 [−9.6; 4.0] | – | – |
| eGFR, MDRD4 (mL/min/1.73 m2) | ||||
| Unadjusted | 78.8 (23.9) | 72.0 (16.7) | – | 0.143 |
| Adjusted | 78.7 [71.5; 85.9] | 72.7 [64.7; 80.6] | 6.0 [−2.5; 14.6] | 0.164 |
| Adjusted change from randomization | 0.3 [−6.9; 7.5] | −5.7 [−13.7; 2.2] | – | – |
| Month 23 postrandomization | ||||
| eGFR, Cockcroft-Gault (mL/min) | ||||
| Unadjusted | 89.4 (29.2) | 79.5 (24.7) | – | 0.104 |
| Adjusted | 88.1 [78.7; 97.4] | 77.5 [67.2; 87.9] | 10.5 [−0.5; 21.5] | 0.061 |
| Adjusted change from randomization | 6.6 [−2.8; 15.9] | −3.9 [−14.3; 6.4] | – | – |
| eGFR, Nankivell (mL/min/1.73 m2) | ||||
| Unadjusted | 93.5 (17.7) | 84.7 (20.3) | – | 0.039 |
| Adjusted | 92.6 [86.4; 98.8] | 84.0 [76.3; 91.8] | 8.6 [0.2; 16.9] | 0.044 |
| Adjusted change from randomization | 2.0 [−5.1; 9.0] | −6.6 [−14.3; 1.2] | – | – |
| eGFR, MDRD4 (mL/min/1.73 m2) | ||||
| Unadjusted | 78.7 (24.7) | 70.5 (20.9) | – | 0.110 |
| Adjusted | 77.5 [69.4; 85.7] | 68.6 [59.7; 77.7] | 8.9 [−0.8; 18.5] | 0.071 |
| Adjusted change from randomization | −0.9 [−9.0; 7.3] | −9.8 [−18.7; −0.8] | – | – |
| Month 35 postrandomization | ||||
| eGFR, Cockcroft-Gault (mL/min) | ||||
| Unadjusted | 88.0 (28.7) | 77.5 (27.4) | – | 0.096 |
| Adjusted | 88.2 [78.6; 97.9] | 78.1 [67.4; 88.8] | 10.1 [−1.3, 21.5] | 0.082 |
| Adjusted change from randomization | 6.8 [−2.9; 16.4] | −3.4 [−14.1; 7.3] | – | – |
| eGFR, Nankivell (mL/min/1.73 m2) | ||||
| Unadjusted | 92.9 (16.3) | 82.4 (21.5) | – | 0.015 |
| Adjusted | 93.6 [86.5; 100.8] | 84.1 [76.3; 91.9] | 9.5 [1.1, 17.9] | 0.028 |
| Adjusted change from randomization | 3.0 [−4.1; 10.2] | −6.5 [−14.3; 1.4] | – | – |
| eGFR, MDRD4 (mL/min/1.73 m2) | ||||
| Unadjusted | 77.5 (23.4) | 67.9 (21.8) | – | 0.059 |
| Adjusted | 78.2 [70.1; 86.2] | 68.8 [60.0; 77.7] | 9.4 [−0.4, 18.9] | 0.053 |
| Adjusted change from randomization | −0.2 [−8.3; 7.8] | −9.6 [−18.4; −0.7] | – | – |
Significant p-values are shown in bold.
Table 1t-Test (between-group comparison).
Table 2ANCOVA.
Unadjusted values are shown as mean (SD). Adjusted data are obtained from ANCOVA analysis, with treatment and center as factors and eGFR at randomization as covariate, and are presented as least square mean values [95% CI].
ANCOVA, analysis of covariance; CI, confidence interval; CNI, calcineurin inhibitor; eGFR, estimated GFR; MDRD, Modification of Diet in Renal Disease (four-variable).