There are limited clinical data regarding prolonged-release tacrolimus (PR-T) use in pediatric transplant recipients. This Phase 2 study assessed the efficacy and safety of PR-T in stable pediatric kidney, liver, and heart transplant recipients (aged ≥5 to ≤16 years) over 1 year following conversion from immediate-release tacrolimus (IR-T), on a 1:1 mg total-daily-dose basis. Endpoints included the incidence of acute rejection (AR), a composite endpoint of efficacy failure (death, graft loss, biopsy-confirmed AR, and unknown outcome), and safety. Tacrolimus dose and whole-blood trough levels (target 3.5-15 ng/ml) were also evaluated. Overall, 79 patients (kidney, n = 48; liver, n = 29; heart, n = 2) were assessed. Following conversion, tacrolimus dose and trough levels remained stable; however, 7.6-17.7% of patients across follow-up visits had trough levels below the target range. Two (2.5%) patients had AR, and 3 (3.8%) had efficacy failure. No graft loss or deaths were reported. No new safety signals were identified. Drug-related treatment-emergent adverse events occurred in 28 patients (35.4%); most were mild, and all resolved. This study suggests that IR-T to PR-T conversion is effective and well tolerated over 1 year in pediatric transplant recipients and highlights the importance of therapeutic drug monitoring to maintain target tacrolimus trough levels.

• Klíčová slova
• calcineurin inhibitor: tacrolimus, clinical trial, heart (allograft) function/dysfunction, immunosuppressant, kidney (allograft) function/dysfunction, liver (allograft) function/dysfunction,
• MeSH
• alografty MeSH
• bezpečnost pacientů MeSH
• biopsie MeSH
• dítě MeSH
• imunosupresiva terapeutické užití   MeSH
• klinické křížové studie MeSH
• léky s prodlouženým účinkem * MeSH
• lidé MeSH
• mladiství MeSH
• předškolní dítě MeSH
• příjemce transplantátu MeSH
• prospektivní studie MeSH
• rejekce štěpu MeSH
• takrolimus aplikace a dávkování   MeSH
• transplantace jater * MeSH
• transplantace ledvin * MeSH
• transplantace srdce * MeSH
• výsledek terapie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• předškolní dítě MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• Názvy látek
• imunosupresiva MeSH
• léky s prodlouženým účinkem * MeSH
• takrolimus MeSH