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- Title
Efficacy and safety of prolonged‐release tacrolimus in stable pediatric allograft recipients converted from immediate‐release tacrolimus – a Phase 2, open‐label, single‐arm, one‐way crossover study.
- Authors
Rubik, Jacek; Debray, Dominique; Kelly, Deirdre; Iserin, Franck; Webb, Nicholas J. A.; Czubkowski, Piotr; Vondrak, Karel; Sellier‐Leclerc, Anne‐Laure; Rivet, Christine; Riva, Silvia; Tönshoff, Burkhard; D'Antiga, Lorenzo; Marks, Stephen D.; Reding, Raymond; Kazeem, Gbenga; Undre, Nasrullah
- Abstract
Summary: 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.
- Subjects
TACROLIMUS; DRUG monitoring; HEART transplant recipients
- Publication
Transplant International, 2019, Vol 32, Issue 11, p1182
- ISSN
0934-0874
- Publication type
Article
- DOI
10.1111/tri.13479