Prospective Study of Mycophenolate Mofetil in Living Donor Renal Allograft Recipents

Park, Ki Il; Moon, Jang Il; Kim, Soon Il; Kim, Yu Seun

Abstract

In this study, we evaluated the safety and efficacy of mycophenolate mofetil(MMF) for the prevention of acute rejection episodes when given in combination with cyclosporine and corticosteroids during the first 6 postoperative months in living donor kidney transplantation. One hundred patients were enrolled; 50 patients received dual immunosuppression (cyclosporine+corticosteroids: control group) and another 50 patients received triple regimen including MMF 2 g/day(cyclosporine+corticosteroids+MMF: study group) through randomization. In the protocol, first-line treatment for acute rejection was a high-dose steroid pulse therapy. Steroid resistant acute rejection was to be treated with polyclonal antilymphocyte agents(ATG). There was no demographic difference between study and control groups. There were 7(14%) acute rejection episodes in the study group and 16(32%) in the control group with statistical significance. Two cases of premature withdrawal were developed in the study group(one severe abdominal pain and another profound leukopenia). The incidence of opportunistic infection was 7(14%) in the study group and 6(12%) in the control group within 6 months post transplantation. There was no statistical differences in serum creatinine level between study and control group at 6 months after transplantation(1.28+/-0.33 mg/dl vs. 1.24+/-0.51 mg/dl). The addition of MMF to a dual immunosuppressive regimen with cyclosporine and corticosteroids seems to lower the incidence and severity of acute rejection in living donor kidney transplantation during the early post-transplantation period. The graft function of the MMF group is comparable with that of the control group. The most common adverse effect of MMF was abdominal pain and diarrhea but almostly resolved with symptomatic treatment. If the frequency of acute rejection during the first 6 months is one of the main determinants of long-term graft survival, it might be expected that MMF could lead to an improved graft survival in combination with cyclosporine and corticosteroids.