Journal ArticleDOI
A randomized, double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients.
Claudio Ponticelli,A Yussim,V. Cambi,Christophe Legendre,G Rizzo,Maurizio Salvadori,Delawir Kahn,H Kashi,Kaija Salmela,Lutz Fricke,Uwe Heemann,J Garcia-Martinez,Robert I. Lechler,Hans Prestele,Danièle Girault +14 more
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TLDR
Basiximab in combination with cyclosporine, steroids, and azathioprine triple therapy was highly effective in reducing the incidence of acute renal allograft rejection without increasing the incidenceof infections and other side effects.Abstract:
Background A double-blind, placebo-controlled, randomized study was performed to assess whether immunoprophylaxis with basiliximab (Simulect) could reduce the incidence of acute rejection in kidney transplant recipients treated with cyclosporine (Neoral), steroids, and azathioprine. Methods Three hundred forty patients received either placebo or basiliximab at a dose of 20 mg, given intravenously on days 0 and 4. All patients received cyclosporine, steroids, and azathioprine. The primary endpoint was the incidence of acute rejection at 6 months. Secondary endpoints included the safety and tolerability of basiliximab and placebo, 1-year patient and graft survival, and significant medical events up to 12 months. Results During the first 6 months posttransplantation, acute rejection occurred in 20.8% of patients given basiliximab versus 34.9% of patients administered placebo (P=0.005). Similarly, there was a reduction in biopsy-proven acute rejection at 6 months in the patients receiving basiliximab (P=0.023). One-year patient survival was 97.6% with basiliximab and 97.1% with placebo, graft survival was 91.5% versus 88.4%, respectively (NS). The adverse-events profile of patients treated with basiliximab was indistinguishable from that of patients treated with placebo. The number of patients with infections was similar (65.5% for basiliximab vs. 65.7% for placebo), including cytomegalovirus infections (17.3% vs. 14.5%, P=0.245). Nine neoplasms (three in the basiliximab group, six in the placebo arm) were recorded up to 1 year from transplantation. Conclusions Basiliximab in combination with cyclosporine, steroids, and azathioprine triple therapy was highly effective in reducing the incidence of acute renal allograft rejection without increasing the incidence of infections and other side effects.read more
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Association of the type of induction immunosuppression with posttransplant lymphoproliferative disorder, graft survival, and patient survival after primary kidney transplantation.
Wida S. Cherikh,H. M. Kauffman,Maureen A. McBride,Jude Maghirang,Lode J. Swinnen,Douglas W. Hanto +5 more
TL;DR: IL-2 receptor antibody induction was associated with the smallest risk of PTLD and improved graft and patient survival and mycophenolate mofetil discharge maintenance immunosuppression wasassociated with a significantly reduced risk ofPTLD and graft loss compared with azathioprine.
Journal ArticleDOI
Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy.
Yvon Lebranchu,Frank Bridoux,Matthias Büchler,Yannick Le Meur,Isabelle Etienne,Olivier Toupance,Bruno Hurault de Ligny,Guy Touchard,Bruno Moulin,Patrick Le Pogamp,O Reigneau,Michel Guignard,Gérard Rifle +12 more
TL;DR: Both strategies give excellent results, despite the differences in patterns, in nonhyperimmunized patients receiving their first cadaveric renal allograft in adult kidney transplant patients.
Journal ArticleDOI
Interleukin 2 receptor antagonists for renal transplant recipients: a meta-analysis of randomized trials.
TL;DR: Given a 40% risk of rejection, seven patients would need treatment with IL-2Ra in addition to standard therapy, to prevent one patient from undergoing rejection, with no definite improvement in graft or patient survival.
Journal ArticleDOI
Interleukin 2 receptor antagonists for kidney transplant recipients
Angela C Webster,L. P. Ruster,Richard McGee,Sandra Matheson,Gail Y. Higgins,Narelle S Willis,Jeremy R. Chapman,Jonathan C. Craig +7 more
TL;DR: There was no difference in graft loss at any time point, or for acute rejection diagnosed clinically, but the was benefit of ATG therapy over IL2Ra for biopsy-proven acute rejection at one year.
Journal ArticleDOI
Sequential protocols using basiliximab versus antithymocyte globulins in renal-transplant patients receiving mycophenolate mofetil and steroids.
Georges Mourad,Lionel Rostaing,Christophe Legendre,Val´erie Garrigue,Eric Thervet,Dominique Durand +5 more
TL;DR: Both ATG and basiliximab, when used for IT in a sequential protocol, are equally effective in terms of graft and patient survival as well as at preventing acute rejection, however, basilixIMab is associated with a lower incidence of certain key adverse events, namely CMV infection, leukopenia, and thrombocytopenia.
References
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Prediction of Creatinine Clearance from Serum Creatinine
Donald W. Cockcroft,M H Gault +1 more
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Journal ArticleDOI
International standardization of criteria for the histologic diagnosis of renal allograft rejection : the Banff working classification of kidney transplant pathology
Kim Solez,Roy A. Axelsen,Hallgrimur Benediktsson,James F. Burdick,Arthur H. Cohen,Robert B. Colvin,Byron P. Croker,Dominique Droz,Michael S. Dunnill,Philip F. Halloran,Pekka Häyry,J. Charles Jennette,Paul Keown,Niels Marcussen,Michael J. Mihatsch,Kunio Morozumi,Bryan D. Myers,Cynthia C. Nast,Steen Olsen,Lorraine C. Racusen,E L Ramos,Seymour Rosen,David H. Sachs,Daniel R. Salomon,Fred Sanfilippo,Regina R. Verani,Eeva von Willebrand,Yutaka Yamaguchi +27 more
TL;DR: A schema for international standardization of nomenclature and criteria for the histologic diagnosis of renal allograft rejection was developed in Banff, Canada on August 2-4, 1991 and validated by the circulation of sets of slides for scoring by participant pathologists.
Journal ArticleDOI
Increased incidence of lymphoproliferative disorder after immunosuppression with the monoclonal antibody OKT3 in cardiac-transplant recipients.
Lode J. Swinnen,Costanzo-Nordin Mr,Susan G. Fisher,E J O'Sullivan,E J O'Sullivan,M R Johnson,M R Johnson,A L Heroux,A L Heroux,G J Dizikes,G J Dizikes,Roque Pifarré,Roque Pifarré,Richard I. Fisher,Richard I. Fisher +14 more
TL;DR: The addition of OKT3 to the immunosuppressive regimen increases the incidence of post-transplantation lymphoproliferative disorder after cardiac transplantation, and the risk increases sharply after cumulative doses greater than 75 mg.
Journal ArticleDOI
Interleukin-2–Receptor Blockade with Daclizumab to Prevent Acute Rejection in Renal Transplantation
Flavio Vincenti,Robert L. Kirkman,Susan Light,Ginny L. Bumgardner,Mark D. Pescovitz,Philip F. Halloran,J. Neylan,Alan H. Wilkinson,Henrik Ekberg,Robert S. Gaston,Lars Bäckman,James F. Burdick +11 more
TL;DR: Daclizumab is a genetically engineered human IgG1 monoclonal antibody that binds specifically to the α chain of the interleukin-2 receptor and may thus reduce the risk of rejection after renal transplantation.