Table 2 Results of analysis of variance (ANCOVA) for the primary endpoint (CoV coefficient of variation of immunosuppressant trough level) and secondary endpoints (eGFR - estimated glomerular filtration rate and the subscales of the SF-12 Short form-12 questionnaire). ANCOVA models for the primary endpoint are adjusted for randomization stratum (male/female and time since Tx </≥ 5 years) and study site. ANCOVA models for the secondary endpoints are adjusted for randomization stratum, study site, and respective baseline value/mean of baseline values at the children’s hospital phase. Displayed are least squared (LS) means per group and for the difference (intervention-control group) with respective 95% confidence intervals (CI) and p-values. mITT modified intention to treat, PP per protocol.
Population | LS mean | LS mean | LS mean difference (95% CI) | p-value | |
---|---|---|---|---|---|
Intervention | Control | ||||
CoV immunosuppressant trough level | mITT (n = 84) | 0.29 | 0.31 | − 0.022 [− 0.19, 0.15] | 0.7953 |
PP (n = 60) | 0.24 | 0.30 | − 0.058 [− 0.23, 0.11] | 0.4898 | |
Mean eGFR at adult hospital phase | mITT (n = 61) | 47.6 | 50.8 | − 3.197 [− 9.57, 3.18] | 0.3172 |
PP (n = 55) | 50.83 | 56.2 | − 5.366 [− 11.59, 0.86] | 0.0890 | |
SF-12 physical subscale at adult hospital phase | mITT (n = 27) | 42.5 | 42.1 | 0.425 [− 1.55, 2.40] | 0.6493 |
PP (n = 24) | 42.6 | 42.0 | 0.651 [− 1.63, 2.93] | 0.5424 | |
SF-12 mental subscale at adult hospital phase | mITT (n = 27) | 42.2 | 43.4 | − 1.198 [− 7.11, 4.71] | 0.6684 |
PP (n = 24) | 44.3 | 44.4 | − 0.06 [− 6.43, 6.32] | 0.9852 |