TRANSPLANT AT ION / RAPID COMMUNICA T ION
2002
This study was undertaken to compare the efficacy and safety of tacrolimus (Tac) with the micro- emulsion formulation of cyclosporin (CyA) in children undergoing renal transplantation. A 6-month, random- ized, prospective, open, parallel group study with an open extension phase was conducted in 18 centers from nine European countries. In total, 196 pediatric patients ( 30 days) insulin use was 3.0% (Tac) and 2.2% (CyA). Post-transplant lymphoproliferative disease was observed in 1 patient in the Tac group and 2 patients in the CyA group. In conclusion, Tac was significantly more effective than CyA microemulsion in preventing acute rejection after renal transplantation in a pediatric population. The overall safety profiles of the two regi- mens were comparable.
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