Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate‐ or prolonged‐release tacrolimus. Issue 10 (19th September 2019)

• Record Type: Journal Article
• Authors: Vondrak, Karel; Parisi, Francesco; Dhawan, Anil; Grenda, Ryszard; Webb, Nicholas J. A.; Marks, Stephen D.; Debray, Dominique; Holt, Richard C. L.; Lachaux, Alain; Kelly, Deirdre; Kazeem, Gbenga; Undre, Nasrullah
• Is Part Of: Clinical transplantation. Volume 33:Issue 10(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-09-19
• Subjects: calcineurin inhibitor: tacrolimus -- heart (allograft) function/dysfunction -- immunosuppressant -- kidney transplantation: living donor -- liver transplantation: living donor; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ctr.13698
• Languages: English
• ISSNs: 0902-0063

Abstract

Abstract: 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.