Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.

Abstract:

METHODS:Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus (TAC) + mycophenolate mofetil (MMF), TAC + azathioprine (AZA), or cyclosporine (Neoral; CsA) + MMF. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function (DGF). Patients were followed-up for 3 years. RESULTS:The results at 3 years corroborate and extend the findings of the 2-year results. Patients with DGF treated with TAC+MMF experienced an increase in 3-year allograft survival compared with patients receiving CsA+MMF (84.1% vs. 49.9%, P=0.02). Patients randomized to either treatment arm containing TAC exhibited numerically superior kidney function when compared with CsA. During the 3 years, new-onset insulin dependence occurred in 6, 3, and 11 patients in the TAC+MMF, CsA+MMF, and TAC+AZA treatment arms, respectively. Furthermore, patients randomized to TAC+MMF received significantly lower doses of MMF as compared with those who received CsA+MMF. CONCLUSION:All three immunosuppressive regimens provided excellent safety and efficacy. However, the best results overall were achieved with TAC+MMF. The combination may provide particular benefit to kidney allograft recipients with DGF. In patients who experienced DGF, graft survival was better at 3 years in those patients receiving TAC in combination with either MMF or AZA as compared with the patients receiving CsA with MMF.

journal_name

Transplantation

journal_title

Transplantation

authors

Gonwa T,Johnson C,Ahsan N,Alfrey EJ,Halloran P,Stegall M,Hardy M,Metzger R,Shield C 3rd,Rocher L,Scandling J,Sorensen J,Mulloy L,Light J,Corwin C,Danovitch G,Wachs M,VanVeldhuisen P,Leonhardt M,Fitzsimmons WE

doi

10.1097/01.TP.0000069831.76067.22

subject

Has Abstract

pub_date

2003-06-27 00:00:00

pages

2048-53

issue

12

eissn

0041-1337

issn

1534-6080

journal_volume

75

pub_type

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