We have located links that may give you full text access.
CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
A 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. The European Mycophenolate Mofetil Cooperative Study Group.
Journal of Urology 1998 January
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.
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.
Full text links
Related Resources
Trending Papers
Heart failure with preserved ejection fraction: diagnosis, risk assessment, and treatment.Clinical Research in Cardiology : Official Journal of the German Cardiac Society 2024 April 12
Proximal versus distal diuretics in congestive heart failure.Nephrology, Dialysis, Transplantation 2024 Februrary 30
Efficacy and safety of pharmacotherapy in chronic insomnia: A review of clinical guidelines and case reports.Mental Health Clinician 2023 October
World Health Organization and International Consensus Classification of eosinophilic disorders: 2024 update on diagnosis, risk stratification, and management.American Journal of Hematology 2024 March 30
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app