This study assessed long-term efficacy/safety of prolonged-release tacrolimus (PR-T) vs immediate-release tacrolimus (IR-T) in de novo pediatric transplant pts. Phase II, parallel-group, multicenter, open-label study in de novo kidney, liver or heart allograft recipients aged <16 years. Pts randomized (1:1) to receive once-daily PR-T or twice-daily IR-T (initial daily dose 0.075mg/kg in heart, 0.3mg/kg in liver/kidney recipients). Target tacrolimus trough level 5–15ng/mL from Day 22. Pts followed-up to Year 1 post randomization. Pts remained on immunosuppressive regimen they were receiving on entry. Efficacy endpoints: biopsy-confirmed acute rejection (BCAR), pt/graft survival, efficacy failure. Adverse events (AEs) were recorded. Overall, 44 pts (20 PR-T; 24 IR-T; mean ±standard deviation [SD] age 10.6±3.1 yrs) received study drug. Baseline characteristics were similar between treatment groups. Mean±SD tacrolimus daily dose was 0.3±0.1mg/kg initially and 0.2±0.1mg/kg at Year 1 with both PR-T and IR-T; at Year 1, tacrolimus trough levels were 6.6±2.2 and 5.4±1.6ng/mL, respectively; BCAR in 1 and 4 pts, respectively. No graft losses/deaths. Efficacy failure occurred in 8 pts (1 PR-T; 7 IR-T). AEs were experienced by most pts, were mild/moderate in 73.8%, and led to study discontinuation in 1 pt (IR-T) (Table). No new safety signals reported. These data support long-term use of PR-T-based immunosuppression in de novo pediatric solid organ allograft recipients.

CITATION INFORMATION: Vondrak K., Parisi F., Dhawan A., Grenda R., Webb N., Marks S., Debray D., Holt R., Lachaux A., Kelly D., Kazeem G., Undre N. Efficacy and Safety of Immediate- and Prolonged-Release Tacrolimus in De Novo Pediatric Transplantation: Randomized Study Am J Transplant. 2017;17 (suppl 3).

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