Mycophenolate mofetil in cadaveric renal transplantation

S. Cho, G. Danovitch, M. Deierhoi, R. Ferguson, T. Gonwa, E. Hodge, C. Johnson, J. Miller, J. L. Neylan, D. Norman, M. D. Pescovitz, H. W. Sollinger, S. J. Tomlanovich, S. Weinstein, W. Wang, M. M. Rees, E. Ramos

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Abstract

This report extends the randomized, double-blind, multicenter trial at 14 centers in the United States that compared triple-therapy regimens containing mycophenolate mofetil (MMF), 2 or 3 g, with a similar regimen containing azathioprine (AZA) in recipients of cadaveric renal allografts. We investigated the continued long-term use of MMF with respect to graft and patient survival, graft function, and safety. All patients who received the study drug (MMF, 2 g, n = 165; MMF, 3 g, n = 166; AZA, n = 164) were included in the 3-year intent-to-treat evaluation of graft and patient survival. At 3 years posttransplantation, the weighted pairwise difference was 6.5%, and 95% confidence interval in graft and patient survival (ie, patients alive with a functioning graft) was -2.1 to 15.1 (P = 0.17) numerically in favor of MMF, 2 g, compared with AZA. Similar to the 1-year data, the principal adverse events were limited to the gastrointestinal and hematologic systems. Although cytomegalovirus (CMV) tissue-invasive disease occurred more often in the MMF- treated groups, most instances occurred during the first year posttransplantation. One patient in the AZA group and one patient in the MMF 2-g group developed lymphoma, whereas three patients in the MMF 3-g group developed lymphoma at 3 years posttransplantation. In conclusion, although the design of the study did not afford adequate statistical power to address survival end points, at 3 years posttransplantation, graft survival, patient survival, renal function, and safety were similar among the AZA, MMF 2-g, and MMF 3-g groups. There was an increased incidence of infection caused by invasive CMV and Aspergillus spp and mucormycosis seen in the MMF groups, but the long-term data confirm MMF is a safe and valuable addition to the range of drugs available to prevent rejection.

Original languageEnglish (US)
Pages (from-to)296-303
Number of pages8
JournalAmerican Journal of Kidney Diseases
Volume34
Issue number2
DOIs
StatePublished - Jan 1 1999

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Keywords

  • Graft survival
  • Mycophenolate mofetil
  • Patient survival
  • Renal transplantation

ASJC Scopus subject areas

  • Nephrology

Cite this

Cho, S., Danovitch, G., Deierhoi, M., Ferguson, R., Gonwa, T., Hodge, E., Johnson, C., Miller, J., Neylan, J. L., Norman, D., Pescovitz, M. D., Sollinger, H. W., Tomlanovich, S. J., Weinstein, S., Wang, W., Rees, M. M., & Ramos, E. (1999). Mycophenolate mofetil in cadaveric renal transplantation. American Journal of Kidney Diseases, 34(2), 296-303. https://doi.org/10.1016/S0272-6386(99)70358-6