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

Hans W. Sollinger, Folkert O. Belzer, Mark H. Deierhoi, Arnold G. Diethelm, Thomas A. Gonwa, Robert S. Kauffman, Goran B. Klintmalm, Sue V. McDiarmid, John Roberts, J. Thomas Rosenthal, Stephen J. Tomlanovich

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118 Scopus citations


RS-61443 (mycophenolate mofetil) inhibits a key enzyme fo 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)513-518
Number of pages6
JournalAnnals of surgery
Issue number4
StatePublished - 1992

ASJC Scopus subject areas

  • Surgery


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