Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus
Jazyk angličtina Země Dánsko Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
Department of Health - United Kingdom
PubMed
31436896
PubMed Central
PMC6900073
DOI
10.1111/ctr.13698
Knihovny.cz E-zdroje
- Klíčová slova
- calcineurin inhibitor: tacrolimus, heart (allograft) function/dysfunction, immunosuppressant, kidney transplantation: living donor, liver transplantation: living donor,
- MeSH
- dítě MeSH
- imunosupresiva terapeutické užití MeSH
- lidé MeSH
- míra přežití MeSH
- mladiství MeSH
- následné studie MeSH
- pooperační komplikace farmakoterapie etiologie MeSH
- předškolní dítě MeSH
- přežívání štěpu účinky léků MeSH
- příjemce transplantátu statistika a číselné údaje MeSH
- prognóza MeSH
- rejekce štěpu farmakoterapie etiologie MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- takrolimus terapeutické užití MeSH
- transplantace orgánů škodlivé účinky 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
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- imunosupresiva MeSH
- takrolimus MeSH
BACKGROUND AND AIMS: This multicenter trial compared immediate-release tacrolimus (IR-T) vs prolonged-release tacrolimus (PR-T) in de novo kidney, liver, and heart transplant recipients aged <16 years. Each formulation had similar pharmacokinetic (PK) profiles. Follow-up efficacy and safety results are reported herein. MATERIALS AND METHODS: Patients, randomized 1:1, received once-daily, PR-T or twice-daily, IR-T within 4 days of surgery. After a 4-week PK assessment, patients continued randomized treatment for 48 additional weeks. At Year 1, efficacy assessments included the number of clinical acute rejections, biopsy-confirmed acute rejection (BCAR) episodes (including severity), patient and graft survival, and efficacy failure (composite of death, graft loss, BCAR, or unknown outcome). Adverse events were assessed throughout. RESULTS: The study included 44 children. At Year 1, mean ± standard deviation tacrolimus trough levels were 6.6 ± 2.2 and 5.4 ± 1.6 ng/mL, and there were 2 and 7 acute rejection episodes in the PR-T and IR-T groups, respectively. No cases of graft loss or death were reported during the study. The overall efficacy failure rate was 18.2% (PR-T n = 1; IR-T n = 7). CONCLUSIONS: In pediatric de novo solid organ recipients, the low incidence of BCAR and low efficacy failure rate suggest that PR-T-based immunosuppression is effective and well tolerated to 1-year post-transplantation.
Alder Hey Children's Hospital Liverpool UK
APHP Hôpital Universitaire Necker Paris France
Astellas Pharma Europe Ltd Chertsey UK
BENKAZ Consulting Ltd Cambridge UK
Birmingham Women's and Children's Hospital Birmingham UK
Great Ormond Street Hospital for Children NHS Foundation Trust London UK
King's College Hospital London UK
Manchester University Foundation Trust Manchester UK
Ospedale Pediatrico Bambino Gesù Rome Italy
The Children's Memorial Health Institute Warsaw Poland
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