Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus
Language English Country Denmark Media print-electronic
Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Grant support
Department of Health - United Kingdom
PubMed
31436896
PubMed Central
PMC6900073
DOI
10.1111/ctr.13698
Knihovny.cz E-resources
- Keywords
- calcineurin inhibitor: tacrolimus, heart (allograft) function/dysfunction, immunosuppressant, kidney transplantation: living donor, liver transplantation: living donor,
- MeSH
- Child MeSH
- Immunosuppressive Agents therapeutic use MeSH
- Humans MeSH
- Survival Rate MeSH
- Adolescent MeSH
- Follow-Up Studies MeSH
- Postoperative Complications drug therapy etiology MeSH
- Child, Preschool MeSH
- Graft Survival drug effects MeSH
- Transplant Recipients statistics & numerical data MeSH
- Prognosis MeSH
- Graft Rejection drug therapy etiology MeSH
- Retrospective Studies MeSH
- Risk Factors MeSH
- Tacrolimus therapeutic use MeSH
- Organ Transplantation adverse effects MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Immunosuppressive Agents MeSH
- Tacrolimus 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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