RS-61443 (mycophenolate mofetil): A multicenter study for refractory kidney transplant rejection

H. W. Sollinger, F. O. Belzer, M. H. Deierhoi, A. G. Diethelm, T. A. Gonwa, R. S. Kauffman, G. B. Klintmalm, S. V. McDiarmid, J. Roberts, J. T. Rosenthal, S. J. Tomlanovich, C. F. Barker, D. E.R. Sutherland

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Abstract

RS-61443 (mycophenolate mofetil) inhibits a key enzyme of the de novo synthesis of purine nucleotides in T and B lymphocytes. The purpose of this study was to evaluate the efficacy of RS-61443 in patients with refractory renal allograft rejection. Patients eligible for the study had previously undergone anti-rejection therapy with high-dose steroids or OKT3 monoclonal antibody. All rejection episodes were proven by renal biopsy. Successful rescue was achieved in 52 (69%) patients. Rescue was more successful when patients were entered with a creatinine of 4 mg/dL or lower (79%), versus a 52% rescue rate in patients entered with a creatinine of 4 mg/dL or above. Major side effects were predominantly gastrointestinal, but there was no overt nephrotoxicity, hepatotoxicity, or bone marrow suppression. The overall infection rate was 40%, with the spectrum of infections characteristic for the highly immunocompromised patient. The conclude that this pilot study suggests that RS-61443 is effective in refractory kidney allograft rejection. Based on this study, prospectively randomized multi-center trails have been planned and are in progress.

Original languageEnglish (US)
Pages (from-to)513-519
Number of pages7
JournalAnnals of surgery
Volume216
Issue number4
DOIs
StatePublished - Nov 5 1992

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ASJC Scopus subject areas

  • Surgery

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Sollinger, H. W., Belzer, F. O., Deierhoi, M. H., Diethelm, A. G., Gonwa, T. A., Kauffman, R. S., Klintmalm, G. B., McDiarmid, S. V., Roberts, J., Rosenthal, J. T., Tomlanovich, S. J., Barker, C. F., & Sutherland, D. E. R. (1992). RS-61443 (mycophenolate mofetil): A multicenter study for refractory kidney transplant rejection. Annals of surgery, 216(4), 513-519. https://doi.org/10.1097/00000658-199210000-00014