Mycophenolate mofetil in pediatric renal transplantation without inductiontherapy: Results after 12 months of treatment

Background. Acute rejection episodes (ARE) of kidney transplants are consid ered as risk factor in the development of chronic rejection, In adult renal transplantation (RTx), ARE have been significantly reduced by mycophenolat e mofetil (MMF) in combination with cyclosporin (CyA) and steroids (Pred). Reports of pediatric RTx on a maintenance immunosuppression with MMF are re stricted to patients (P) after antibody induction therapy. Methods. The efficacy and safety of MMF combined with CyA and Pred in pedia tric RTx without induction therapy were evaluated in an open-labeled multic enter study. Results. From 10/1996 to 6/1999, 65 pediatric P (MMF group) were followed f or at least 6 months, 58 of 65 for 12 months. These P were compared with 54 retrospectively analyzed pediatric P who were transplanted between 1990 an d 1996 and had received CyA, Pred, and azathioprine for immunosuppression ( historic AZA group). Within the first 6 months after RTx, 18 of 65 (MMF gro up) and 32 of 54 (historic AZA group) P showed clinical signs of acute reje ction (P<0.01), Thereafter only one further P in the MMF group developed a first ARE, Graft loss due to rejection occurred in one MMF- and seven AZA-t reated P (P<0.05). The creatinine-clearance 3 and 6 months after RTx was hi gher in the MMF group. Major adverse events (MMF group) included infections of the urinary and the upper respiratory tract, diarrhea, and leukopenia C ytomegalovirus-infection occurred in 13 P and 2 P developed cytomegalovirus disease. One P developed PTLD 10 months after RTx and recovered after the reduction of immunosuppression. Conclusions. The combination of MMF, CyA, and Pred reduced ARE in pediatric RTx without incurring major side effects.