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/sirolimus with tacrolimus/mycophenolate mofetil 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. Outcome measures 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, estimated GFR was significantly lower in the tacrolimus/sirolimus group compared with the tacrolimus/mycophenolate mofetil group (47.7 versus 59.6 ml/min per 1.73 m(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.
RCT Entities:
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/sirolimus with tacrolimus/mycophenolate mofetil 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. Outcome measures 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, estimated GFR was significantly lower in the tacrolimus/sirolimus group compared with the tacrolimus/mycophenolate mofetil group (47.7 versus 59.6 ml/min per 1.73 m(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.
Authors: Herwig-Ulf Meier-Kriesche; Jesse D Schold; Titte R Srinivas; Richard J Howard; Shiro Fujita; Bruce Kaplan Journal: Am J Transplant Date: 2005-09 Impact factor: 8.086
Authors: Brian J Nankivell; Richard J Borrows; Caroline L-S Fung; Philip J O'Connell; Richard D M Allen; Jeremy R Chapman Journal: N Engl J Med Date: 2003-12-11 Impact factor: 91.245
Authors: Eveline Van Gurp; Jesus Bustamante; Antonio Franco; Lionel Rostaing; Thomas Becker; Eric Rondeau; Zenon Czajkowski; Andrzej Rydzewski; Antonio Alarcon; Petr Bachleda; Jiri Samlik; Dirk Burmeister; Luis Pallardo; Marie-Christine Moal; Boleslaw Rutkowski; Zbigniew Wlodarczyk Journal: J Transplant Date: 2010-10-05
Authors: Anil S Paramesh; Sasan Roayaie; Yvette Doan; Myron E Schwartz; Sukru Emre; Thomas Fishbein; Sander Florman; Gabriel E Gondolesi; Nancy Krieger; Scott Ames; Jonathan S Bromberg; Enver Akalin Journal: Clin Transplant Date: 2004-02 Impact factor: 2.863
Authors: Bruce Kaplan; Jesse Schold; Titte Srinivas; Karl Womer; David P Foley; Pamela Patton; Richard Howard; Herwig-Ulf Meier-Kriesche Journal: Am J Transplant Date: 2004-10 Impact factor: 8.086
Authors: Deirdre Hahn; Elisabeth M Hodson; Lorraine A Hamiwka; Vincent Ws Lee; Jeremy R Chapman; Jonathan C Craig; Angela C Webster Journal: Cochrane Database Syst Rev Date: 2019-12-16
Authors: Lorenzo Gallon; Opas Traitanon; Nedjema Sustento-Reodica; Joseph Leventhal; M Javeed Ansari; Ricardo C Gehrau; Venkatesh Ariyamuthu; Sacha A De Serres; Antonio Alvarado; Darshika Chhabra; James M Mathew; Nader Najafian; Valeria Mas Journal: Kidney Int Date: 2014-10-29 Impact factor: 10.612
Authors: Opas Traitanon; James M Mathew; Aneesha Shetty; Sai Vineela Bontha; Daniel G Maluf; Yvonne El Kassis; Sook H Park; Jing Han; M Javeed Ansari; Joseph R Leventhal; Valeria Mas; Lorenzo Gallon Journal: PLoS One Date: 2019-05-28 Impact factor: 3.240