Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria

Detalhes bibliográficos
Autor(a) principal: Ruiz, JC
Data de Publicação: 2007
Outros Autores: Campistol, JM, Sanchez-Fructuoso, A, Mota, A, Ginyo, JM, Paul, L, Castro-Henriques, A
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.4/197
Resumo: Proteinuria has been reported in several papers after conversion from calcineurin inhibitors to Sirolimus (SRL), but this complication has not been analyzed in randomized clinical trials using de novo SRL. It is not known whether de novo use of SRL is a risk factor for proteinuria. We analyzed a series of patients included in a big multicenter randomized trial (RMR trial) corresponding to all patients in Spain and Portugal with respect to this issue. We retrospectively evaluated 24-hour proteinuria in all the patients during the study period (5 years postransplant) for comparison between treatment arms group A, continuous cyclosporine (CyA) + SRL and group B SRL with CyA elimination at 3 months postransplant. The elimination of CyA after the third month was not followed by significant changes in proteinuria. Nevertheless, during the last year of follow-up (between 48 and 60 months postransplant) an impressive increase in proteinuria was observed in group A. This surprising finding seemed to be a consequence of a protocol amendment that recommended CyA elimination in patients of group A, due to poorer results in the intermediate analysis of the trial. This fact suggests that the hemodynamic changes induced by elimination of the vasoconstrictor CyA might be responsible for the proteinuria but only in the long term probably when significant pathological lesions are already present. This finding argues for earlier conversion.
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spelling Early sirolimus use with cyclosporine elimination does not induce progressive proteinuriaCiclosporinaImunossupressoresSirolimusTransplantação de RimProteinuria has been reported in several papers after conversion from calcineurin inhibitors to Sirolimus (SRL), but this complication has not been analyzed in randomized clinical trials using de novo SRL. It is not known whether de novo use of SRL is a risk factor for proteinuria. We analyzed a series of patients included in a big multicenter randomized trial (RMR trial) corresponding to all patients in Spain and Portugal with respect to this issue. We retrospectively evaluated 24-hour proteinuria in all the patients during the study period (5 years postransplant) for comparison between treatment arms group A, continuous cyclosporine (CyA) + SRL and group B SRL with CyA elimination at 3 months postransplant. The elimination of CyA after the third month was not followed by significant changes in proteinuria. Nevertheless, during the last year of follow-up (between 48 and 60 months postransplant) an impressive increase in proteinuria was observed in group A. This surprising finding seemed to be a consequence of a protocol amendment that recommended CyA elimination in patients of group A, due to poorer results in the intermediate analysis of the trial. This fact suggests that the hemodynamic changes induced by elimination of the vasoconstrictor CyA might be responsible for the proteinuria but only in the long term probably when significant pathological lesions are already present. This finding argues for earlier conversion.ElsevierRIHUCRuiz, JCCampistol, JMSanchez-Fructuoso, AMota, AGinyo, JMPaul, LCastro-Henriques, A2008-11-27T15:16:01Z20072007-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.4/197engTransplant Proc. 2007 Sep;39(7):2151-2info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-11T14:21:20Zoai:rihuc.huc.min-saude.pt:10400.4/197Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T18:03:02.559699Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
title Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
spellingShingle Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
Ruiz, JC
Ciclosporina
Imunossupressores
Sirolimus
Transplantação de Rim
title_short Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
title_full Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
title_fullStr Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
title_full_unstemmed Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
title_sort Early sirolimus use with cyclosporine elimination does not induce progressive proteinuria
author Ruiz, JC
author_facet Ruiz, JC
Campistol, JM
Sanchez-Fructuoso, A
Mota, A
Ginyo, JM
Paul, L
Castro-Henriques, A
author_role author
author2 Campistol, JM
Sanchez-Fructuoso, A
Mota, A
Ginyo, JM
Paul, L
Castro-Henriques, A
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv RIHUC
dc.contributor.author.fl_str_mv Ruiz, JC
Campistol, JM
Sanchez-Fructuoso, A
Mota, A
Ginyo, JM
Paul, L
Castro-Henriques, A
dc.subject.por.fl_str_mv Ciclosporina
Imunossupressores
Sirolimus
Transplantação de Rim
topic Ciclosporina
Imunossupressores
Sirolimus
Transplantação de Rim
description Proteinuria has been reported in several papers after conversion from calcineurin inhibitors to Sirolimus (SRL), but this complication has not been analyzed in randomized clinical trials using de novo SRL. It is not known whether de novo use of SRL is a risk factor for proteinuria. We analyzed a series of patients included in a big multicenter randomized trial (RMR trial) corresponding to all patients in Spain and Portugal with respect to this issue. We retrospectively evaluated 24-hour proteinuria in all the patients during the study period (5 years postransplant) for comparison between treatment arms group A, continuous cyclosporine (CyA) + SRL and group B SRL with CyA elimination at 3 months postransplant. The elimination of CyA after the third month was not followed by significant changes in proteinuria. Nevertheless, during the last year of follow-up (between 48 and 60 months postransplant) an impressive increase in proteinuria was observed in group A. This surprising finding seemed to be a consequence of a protocol amendment that recommended CyA elimination in patients of group A, due to poorer results in the intermediate analysis of the trial. This fact suggests that the hemodynamic changes induced by elimination of the vasoconstrictor CyA might be responsible for the proteinuria but only in the long term probably when significant pathological lesions are already present. This finding argues for earlier conversion.
publishDate 2007
dc.date.none.fl_str_mv 2007
2007-01-01T00:00:00Z
2008-11-27T15:16:01Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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url http://hdl.handle.net/10400.4/197
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Transplant Proc. 2007 Sep;39(7):2151-2
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dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
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