Safety and efficacy of an alternative basiliximab (Simulect) regiment after renal transplantation: administration of a single 40-mg dose on the first postoperative day in patients receiving triple therapy with azathioprine
2003; Springer Science+Business Media; Volume: 16; Issue: 1 Linguagem: Inglês
10.1111/j.1432-2277.2003.tb00222.x
ISSN1432-2277
AutoresI Matl, Petr Bachleda, M Lao, R Michalský, P Navrátil, Vladislav Třeška, H. Prestele, Mark Matthisson, Alexander Korn,
Tópico(s)Renal Diseases and Glomerulopathies
ResumoTransplant InternationalVolume 16, Issue 1 p. 45-52 Free to Read Safety and efficacy of an alternative basiliximab (Simulect) regiment after renal transplantation: administration of a single 40-mg dose on the first postoperative day in patients receiving triple therapy with azathioprine Ivo Matl, Corresponding Author Ivo Matl Clinic of Nephrology, Institute for Clinical and Experimental Medicine, Videnska 1958, 14021 Prague 4, Czech RepublicTel.: +420-2-61362163, Fax: +420-2-61363168, Email:[email protected]Search for more papers by this authorPetr Bachleda, Petr Bachleda First Department of Surgery, University Hospital, Olomouc, Czech RepublicSearch for more papers by this authorMieczyslaw Lao, Mieczyslaw Lao Medical University of Warsaw, Nowogrodzka, Warsaw, PolandSearch for more papers by this authorRudolf Michalský, Rudolf Michalský Department of Surgery, University Hospital, Ostrava, Czech RepublicSearch for more papers by this authorPavel Navrátil, Pavel Navrátil Department of Nephrology, University Hospital, Hradec Kralove, Czech RepublicSearch for more papers by this authorVladislav Třeška, Vladislav Třeška Department of Surgery, University Hospital, Plzen, Czech RepublicSearch for more papers by this authorHans Prestele, Hans Prestele Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this authorMark Matthisson, Mark Matthisson Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this authorAlexander Korn, Alexander Korn Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this author Ivo Matl, Corresponding Author Ivo Matl Clinic of Nephrology, Institute for Clinical and Experimental Medicine, Videnska 1958, 14021 Prague 4, Czech RepublicTel.: +420-2-61362163, Fax: +420-2-61363168, Email:[email protected]Search for more papers by this authorPetr Bachleda, Petr Bachleda First Department of Surgery, University Hospital, Olomouc, Czech RepublicSearch for more papers by this authorMieczyslaw Lao, Mieczyslaw Lao Medical University of Warsaw, Nowogrodzka, Warsaw, PolandSearch for more papers by this authorRudolf Michalský, Rudolf Michalský Department of Surgery, University Hospital, Ostrava, Czech RepublicSearch for more papers by this authorPavel Navrátil, Pavel Navrátil Department of Nephrology, University Hospital, Hradec Kralove, Czech RepublicSearch for more papers by this authorVladislav Třeška, Vladislav Třeška Department of Surgery, University Hospital, Plzen, Czech RepublicSearch for more papers by this authorHans Prestele, Hans Prestele Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this authorMark Matthisson, Mark Matthisson Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this authorAlexander Korn, Alexander Korn Clinical Research, Novartis Pharma AG, Basle, SwitzerlandSearch for more papers by this author First published: 11 March 2005 https://doi.org/10.1111/j.1432-2277.2003.tb00222.xCitations: 8AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat Abstract Abstract This was a multi-center, open-label, randomized, dose-comparative study on 202 renal transplantation patients. We evaluated for the first time an alternative dosing regimen for basiliximab, consisting of a single 40-mg intravenous dose on day 1 post-transplantation plus triple therapy, in comparison with the conventional two-dose regimen (2 h before transplantation and on day 4) plus triple therapy. At 6 months, the incidence of acut re rejection was low: 22.5% of patients in the basiliximab 2×20-mg group and 20.0% of patients in the basiliximab 1×40-mg group experienced an acute rejection episode (P= 0.628) (biopsy-proven rejection: 19.6% and 17.0%, P= 0.585). There was no statistically significant difference in any of the secondary efficacy parameters. The incidence of graft loss by 12 months was 4.9% and 6.0% in the 2×20-mg and 1×40-mg group, respectively (P= 0.73). No differences were observed between the dosage groups with regards to safety assessments (adverse events (AEs), infections, vital signs, laboratory safety evaluations, and physical examinations). The data reveal that basiliximab can be safetly and effectively administered as a single 40-mg dose on day 1 after renal transplantation as a therapeutic option to the established 2×20-mg dosing regimen. This alterantive dosing regimen may be of significant convenience under circumstances when a first dose of basiliximab was not given prior to transplantation. Both regimens can cnoventiently be used during the initial hospitalization of the patient. reference 1 Amlot, PL, Rawlings, E, Fernando, ON, Griffin, PJ, Heinrich, G, Schreier, MH, Castaigne, JP, Moore, R, Sweny, P (1995) Prolonged action of a chimeric interleukin-2 receptor (CD25) monoclonal antibody used in cadaveric renal transplantation. 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