Background and objectives: The optimal maintenance immunosuppressive regimen to improve long-term renal allograft function and graft survival is yet to be determined. Design, setting, participants, & measurements: This observational study prospectively compared tacrolimus/sirolimuswith tacrolimus/mycophenolatemofetil in renal transplant recipients using a prednisone-free regimen with over 8.5 years of follow-up. Patients received methylprednisonlone and anti-IL2 receptor antagonist (Basiliximab) induction and were blindly randomized to either the tacrolimus/mycophenolate mofetil (n=45) or tacrolimus/sirolimus (n=37) groups. Outcomemeasures included patient and renal allograft survival, incidence of acute rejection, and estimated GFR. Results: The tacrolimus/mycophenolate mofetil group compared with the tacrolimus/sirolimus group had overall better renal allograft survival (91% versus 70%, P=0.02); 13 patients (35.1%) in the tacrolimus/sirolimus group and 8 patients (17.8%) in the tacrolimus/mycophenolate mofetil group experienced biopsy-proven acute cellular rejection (P=0.07). By 3 months post-transplant, estimatedGFRwas significantly lower in the tacrolimus/sirolimus group compared with the tacrolimus/mycophenolatemofetil group (47.7 versus 59.6ml/min per 1.73m 2, P=0.0002), and this trend persisted throughout the follow-up period. Also, the slope of decline in the tacrolimus/sirolimus group was significantly steeper than in the tacrolimus/mycophenolate mofetil group. Conclusions: This study shows that, in a prednisone-free immunosuppressive regimen, long-term renal graft survival and function are significantly worse in the tacrolimus/sirolimus group than the tacrolimus/mycophenolate mofetil group. The synergistic nephrotoxic effect and higher acute rejection rates in the tacrolimus/sirolimus compared with the tacrolimus/mycophenolate mofetil group adversely affect graft survival.
|Original language||English (US)|
|Number of pages||9|
|Journal||Clinical Journal of the American Society of Nephrology|
|State||Published - Mar 1 2012|
ASJC Scopus subject areas
- Critical Care and Intensive Care Medicine