Study assessed long-term efficacy/safety of prolonged-release tacrolimus (PR-T) in stable solid organ allograft recipients (aged 5–16 yrs) who participated in a multicenter, Phase II pharmacokinetics study of one-way conversion from twice-daily immediate-release tacrolimus (IR-T) to once-daily PR-T. Pts continued to receive their IR-T-based regimen on Days 1–7. Day 8, pts converted from IR-T to PR-T (1:1mg total daily dose). Exposure to tacrolimus was similar for IR-T (Day 7) and PR-T (Day 14). During 12-month follow-up, efficacy endpoints were biopsy-confirmed acute rejection (BCAR), pt/graft survival, efficacy failure. Secondary endpoint: safety (adverse events [AEs]). Overall, 79 pts (kidney, n=48; liver, n=29; heart, n=2) were included (mean ±standard deviation [SD] age 11.6±2.8 yrs). Mean±SD tacrolimus daily dose was 0.10±0.05 and 0.09±0.05mg/kg at baseline and Month 12, respectively; tacrolimus trough levels were 5.1±1.9 and 5.2±2.1ng/mL. BCAR was reported in one kidney transplant recipient. Pt/graft survival was 100%. AEs were experienced by 67 (84.8%) pts, were mild in 56.7%, and led to study discontinuation in one pt (Table). No new safety issues were reported. The data support long-term PR-T-based immunosuppression use in stable pediatric transplant pts converted from IR-T.

CITATION INFORMATION: Undre N., Rubik J., Debray D., Kelly D., Iserin F., Webb N., Czubkowski P., Vondrak K., Sellier-Leclerc A-.L., Riva S., Tönshoff B., D'Antiga L., Marks S., Reding R., Kazeem G. Long-Term Efficacy and Safety of Prolonged-Release Tacrolimus in Stable Pediatric Allograft Recipients Converted from Immediate-Release Tacrolimus Am J Transplant. 2017;17 (suppl 3).

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