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• W2012504698 abstract "No AccessJournal of UrologyClinical Urology: Original Articles1 Jan 1998A PLACEBO CONTROLLED STUDY OF MYCOPHENOLATE MOFETIL USED IN COMBINATION WITH CYCLOSPORINE AND CORTICOSTEROIDS FOR THE PREVENTION OF ACUTE REJECTION IN RENAL ALLOGRAFT RECIPIENTS: 1-YEAR RESULTS M. Wiesel and S. Carl M. WieselM. Wiesel More articles by this author and S. CarlS. Carl More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)64000-XAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We performed a randomized, double-blind, multicenter, placebo controlled study to compare the efficacy and safety of 2 oral doses of mycophenolate mofetil with placebo for prevention of acute rejection episodes following first or second cadaveric renal allograft transplantation. Materials and Methods: A total of 491 patients were enrolled in the study and randomly allocated to receive placebo (166), 1 gm. mycophenolate mofetil twice daily (165) or 1.5 gm. mycophenolate mofetil twice daily (160). Patients were given concomitant immunosuppression with cyclosporine and corticosteroids. Treatment with mycophenolate mofetil was initiated within 72 hours of transplantation and was continued for at least 1 year. Results: The percentages of patients who experienced biopsy proved rejection or withdrew early from the trial for any reason were significantly reduced with 2 gm. (30.3%) and 3 gm. (38.8%) mycophenolate mofetil compared to placebo (56.0%) (p <0.001). The biopsy proved rejection rates of the placebo, and 2 gm. and 3 gm. mycophenolate mofetil treatment arms were 46.4, 17.6 and 13.8%, respectively. There were fewer patients in the 2 gm. (28.5%) and 3 gm. (24.4%) mycophenolate mofetil groups compared to the placebo (51.8%) group, who received full courses of corticosteroids or antilymphocyte agents for treatment of rejection episodes in the first 6 months after renal transplantation. There was a greater incidence of gastrointestinal adverse events, leukopenia and opportunistic events in the mycophenolate mofetil treatment groups. Conclusions: Mycophenolate mofetil was shown to reduce significantly the number of patients who experienced biopsy proved rejection episodes or treatment failure during the first year after renal transplantation, and was well tolerated. References 1 : The incidence and impact of early rejection episodes on graft outcome in recipients of first cadaver kidney transplants.. Transplantation1992; 53: 323. Google Scholar 2 : Rejection episodes.. In: Clinical Transplants.. Edited by . Los Angeles, California: UCLA Tissue Typing Laboratory1992. Google Scholar 3 : The impact of acute rejection episodes on long-term graft function and outcome in 1347 primary renal transplants treated by 3 cyclosporin regimens.. Transplantation1993; 56: 307. Google Scholar 4 : Risk factors for chronic rejection in renal allograft recipients.. Transplantation1993; 55: 752. Google Scholar 5 : Predictors of long-term primary cadaveric renal transplant survival.. Clin. Transplant.1993; 7: 345. Google Scholar 6 : A randomised trial of cyclosporin and prednisolone versus cyclosporin, azathioprine, and prednisolone in primary cadaveric renal transplantation.. Transplantation1992; 54: 624. Google Scholar 7 : Survival trends in long-term first cadaver donor kidney transplants.. In: Clinical Transplants.. Edited by . Los Angeles, California: UCLA Tissue Typing Laboratory1991. Google Scholar 8 : Mycophenolic acid morpholinoethylester (RS-6143) is a new immunosuppressant that prevents and halts heart allograft rejection by selective inhibition of T and B cell purine synthesis.. Transplant. Proc.1990; 22: 1659. Google Scholar 9 : RS-61443 allows islet allografting and specific tolerance induction in adult mice.. Transplant. Proc.1990; 22: 1659. Google Scholar 10 : Tolerance induction in adult mice: cyclosporine inhibits RS-61443-induced tolerance.. Transplant. Proc.1991; 23: 733. Google Scholar 11 : RS-61443, a new, potent immunosuppressive agent.. Transplantation1990; 51: 27. Google Scholar 12 : RS-61443 for reversal of acute rejection in canine renal allografts.. Surgery1991; 110: 736. Google Scholar 13 : RS-61443-a phase I clinical trial and pilot rescue study.. Transplantation1992; 53: 428. Google Scholar 14 : One-year follow-up results of a phase I trial mycophenolate mofetil (RS-61443) in cadaveric renal transplantation.. Transplant. Proc.1993; 25: 693. Google Scholar 15 : Controlled trial of RS-61443 in renal transplant patients receiving cyclosporine monotherapy.. Transplant. Proc.1993; 25: 695. Google Scholar 16 : RS-61443: rescue therapy in refractory kidney transplant rejection.. Transplant. Proc.1993; 25: 698. Google Scholar 17 : RS-61443 (mycophenolate mofetil): a multicentre study for refractory kidney transplant rejection.. Ann. Surg.1992; 216: 513. Google Scholar 18 : Experience with mycophenolate mofetil (RS-61443) in renal transplantation at a single centre.. Ann. Surg.1993; 217: 476. Google Scholar 19 : Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients.. Transplantation1995; 60: 225. Google Scholar 20 : A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation.. Transplantation1996; 61: 1029. Google Scholar 21 : Placebo controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection.. Lancet1995; 345: 1321. Google Scholar 22 : International standardisation of criteria for the histologic diagnosis of renal allograft rejection: the Banff working classifikation of kidney transplant pathology.. Kidney Int.1993; 44: 411. Google Scholar From the Department of Urology, University of Heidelberg, Heidelberg, GermanyAccepted for publication June 20, 1997For the European Mycophenolate Mofetil Cooperative Study Group; Participating centers: Med. Hochschule, Hannover, Hannover, Germany; Hospital de Bellvitge, Barcelona, Spain; UZ Gasthuisberg, Leuven, Belgium; Hospital 12 de Octobre, Madrid, Spain; National Hospital, Oslo, Norway; University Hospital, Leeds, United Kingdom; University Hospital, Nantes, France; University Hospital, Groningen, Netherlands; University of Essen, Essen, Germany; Huddinge Hospital, Stockholm, Sweden; Sahlgrenska Hospital, Goteborg, Sweden; University of Heidelberg, Heidelberg, Germany; University of Erlangen, Erlangen, Germany; Hopital Henri Mondor, Creteil, France; University Hospital, Uppsala, Sweden; Ospedale Maggiore, Milano, Italy; Kantonsspital Basel, Basel, Switzerland; University Hospital Utrecht, Utrecht, The Netherlands, and Nottingham City Hospital, Roche, Basel, Switzerland© 1998 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited by (2018) EDITORIAL COMMENTJournal of Urology, VOL. 160, NO. 6 Part 1, (1985-1986), Online publication date: 1-Dec-1998. Volume 159Issue 1January 1998Page: 28-33 Advertisement Copyright & Permissions© 1998 by American Urological Association, Inc.MetricsAuthor Information M. Wiesel More articles by this author S. Carl More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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