Randomized trial of immunosuppressive regimens in renal transplantation

Giselle Guerra, Gaetano Ciancio, Jeffrey J. Gaynor, Alberto Zarak, Randolph Brown, Lois Hanson, Junichiro Sageshima, David Roth, Linda Chen, Warren Kupin, Lissett Tueros, Phillip Ruiz, Alan S. Livingstone, George W. Burke

Research output: Contribution to journalArticlepeer-review

55 Scopus citations


The optimal long-term regimen for immunosuppression for kidney transplant recipients is unknown. We conducted a randomized trial involving 150 kidney transplant recipients to compare tacrolimus/sirolimus, tacrolimus/mycophenolate mofetil (MMF), and cyclosporine/sirolimus. All patients received daclizumab induction and maintenance corticosteroids. Median follow-up was 8 yr post-transplant. Acute rejection (AR) occurred significantly less often among those treated with tacrolimus/MMF (12%) than among those treated with tacrolimus/sirolimus (30%) or cyclosporine/sirolimus (28%). Mean estimated GFR was consistently higher in the tacrolimus/MMF arm, especially after controlling for donor age in a multivariable model during the first 36 mo (P ≲ 0.008). The rate of dying with a functioning graft was significantly higher among those treated with tacrolimus/sirolimus (26%) than among those treated with tacrolimus/ MMF (12%) or cyclosporine/sirolimus (4%). We did not observe significant differences in actuarial graft survival at 8 yr post-transplant between the groups. Patient noncompliance seemed responsible for 45% (13/29) of observed graft failures, with 11 of these occurring after 36 mo. Significantly more viral infections, protocol violations, and need for antilipid therapy occurred among patients receiving sirolimus, but we did not observe differences between the groups with regard to infections requiring hospitalization or new-onset diabetes. Taken together, these results suggest that maintenance therapy with tacrolimus/MMF is more favorable than either tacrolimus/sirolimus or cyclosporine/sirolimus.

Original languageEnglish (US)
Pages (from-to)1758-1768
Number of pages11
JournalJournal of the American Society of Nephrology
Issue number9
StatePublished - Sep 1 2011
Externally publishedYes

ASJC Scopus subject areas

  • Nephrology


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