Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis
Autor(a) principal: | |
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Data de Publicação: | 2014 |
Outros Autores: | , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UFRGS |
Texto Completo: | http://hdl.handle.net/10183/119170 |
Resumo: | OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians’ discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9¡1.2 and 10.96¡1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy and safety. |
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Picon, Paulo DornellesPribbernow, Suzane Cristina MilechPrompt, Carlos AlbertoSchacher, Suzana ComunelloAntunes, Verônica Verleine HörbeChiella, Bianca Paula MentzOliveira, Fabiane LopesSouza, Célia Mariana Barbosa deSchacher, Fernando Comunello2015-07-15T02:08:05Z20141807-5932http://hdl.handle.net/10183/119170000953923OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians’ discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9¡1.2 and 10.96¡1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy and safety.application/pdfengClinics. São Paulo. Vol. 69, n. 8 (Ago. 2014), p. 547-553Ensaio clínico controlado aleatórioInsuficiência renal crônicaAnemiaDiálise renalEritropoetinaEpoetin alfaRandomized controlled trialChronic kidney diseaseAnemiaHemodialysisErythropoietinRandomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysisinfo:eu-repo/semantics/articleinfo:eu-repo/semantics/otherinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFRGSinstname:Universidade Federal do Rio Grande do Sul (UFRGS)instacron:UFRGSORIGINAL000953923.pdf000953923.pdfTexto completo (inglês)application/pdf836436http://www.lume.ufrgs.br/bitstream/10183/119170/1/000953923.pdfb45ffa0b9841a9f14efa844d38b71962MD51TEXT000953923.pdf.txt000953923.pdf.txtExtracted Texttext/plain31237http://www.lume.ufrgs.br/bitstream/10183/119170/2/000953923.pdf.txta917bc38a4e3367d4750d8d036efe386MD52THUMBNAIL000953923.pdf.jpg000953923.pdf.jpgGenerated Thumbnailimage/jpeg2151http://www.lume.ufrgs.br/bitstream/10183/119170/3/000953923.pdf.jpg269e12e4c8f754d2ff9de6a207c96cc4MD5310183/1191702023-08-18 03:39:07.586801oai:www.lume.ufrgs.br:10183/119170Repositório de PublicaçõesPUBhttps://lume.ufrgs.br/oai/requestopendoar:2023-08-18T06:39:07Repositório Institucional da UFRGS - Universidade Federal do Rio Grande do Sul (UFRGS)false |
dc.title.pt_BR.fl_str_mv |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
title |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
spellingShingle |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis Picon, Paulo Dornelles Ensaio clínico controlado aleatório Insuficiência renal crônica Anemia Diálise renal Eritropoetina Epoetin alfa Randomized controlled trial Chronic kidney disease Anemia Hemodialysis Erythropoietin |
title_short |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
title_full |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
title_fullStr |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
title_full_unstemmed |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
title_sort |
Randomized double-blind clinical trial of a new human epoetin versus a commercially available formula for anemia control in patients on hemodialysis |
author |
Picon, Paulo Dornelles |
author_facet |
Picon, Paulo Dornelles Pribbernow, Suzane Cristina Milech Prompt, Carlos Alberto Schacher, Suzana Comunello Antunes, Verônica Verleine Hörbe Chiella, Bianca Paula Mentz Oliveira, Fabiane Lopes Souza, Célia Mariana Barbosa de Schacher, Fernando Comunello |
author_role |
author |
author2 |
Pribbernow, Suzane Cristina Milech Prompt, Carlos Alberto Schacher, Suzana Comunello Antunes, Verônica Verleine Hörbe Chiella, Bianca Paula Mentz Oliveira, Fabiane Lopes Souza, Célia Mariana Barbosa de Schacher, Fernando Comunello |
author2_role |
author author author author author author author author |
dc.contributor.author.fl_str_mv |
Picon, Paulo Dornelles Pribbernow, Suzane Cristina Milech Prompt, Carlos Alberto Schacher, Suzana Comunello Antunes, Verônica Verleine Hörbe Chiella, Bianca Paula Mentz Oliveira, Fabiane Lopes Souza, Célia Mariana Barbosa de Schacher, Fernando Comunello |
dc.subject.por.fl_str_mv |
Ensaio clínico controlado aleatório Insuficiência renal crônica Anemia Diálise renal Eritropoetina |
topic |
Ensaio clínico controlado aleatório Insuficiência renal crônica Anemia Diálise renal Eritropoetina Epoetin alfa Randomized controlled trial Chronic kidney disease Anemia Hemodialysis Erythropoietin |
dc.subject.eng.fl_str_mv |
Epoetin alfa Randomized controlled trial Chronic kidney disease Anemia Hemodialysis Erythropoietin |
description |
OBJECTIVES: Anemia is a common complication among chronic kidney disease patients on hemodialysis, occurring mostly due to erythropoietin deficiency. This randomized noninferiority trial sought to compare the efficacy and safety of a new epoetin formulation developed by Bio-Manguinhos, a biologics manufacturer affiliated with the Brazilian government, with those of a commercially available product currently used in Brazil (a biosimilar epoetin formulation). METHODS: The sample size needed to enable demonstration of noninferiority with a statistical power of 85% for a between-group difference in hemoglobin levels of no more than 1.5 g/dL was calculated. In total, 74 patients were randomly assigned to receive the epoetin formulation from Bio-Manguinhos (n = 36) or the biosimilar epoetin formulation (n = 38) in a double-blind fashion. The inclusion criteria were current epoetin therapy and stable hemoglobin levels for at least 3 months prior to the study. The primary and secondary outcomes were mean monthly hemoglobin levels and safety, respectively. The dose was calculated according to international criteria and adjusted monthly in both groups according to hemoglobin levels and at the assistant physicians’ discretion. Iron storage was estimated at baseline and once monthly. Clinicaltrials.gov: NCT01184495. RESULTS: The study was conducted for 6 months after randomization. The mean baseline hemoglobin levels were 10.9¡1.2 and 10.96¡1.2 g/dL (p = 0.89) in the Bio-Manguinhos epoetin and biosimilar epoetin groups, respectively. During the study period, there was no significant change in hemoglobin levels in either group (p = 0.055, ANOVA). The epoetin from Bio-Manguinhos was slightly superior in the last 3 months of follow-up. The adverse event profiles of the two formulations were also similar. CONCLUSIONS: The epoetin formulations tested in this study are equivalent in efficacy and safety. |
publishDate |
2014 |
dc.date.issued.fl_str_mv |
2014 |
dc.date.accessioned.fl_str_mv |
2015-07-15T02:08:05Z |
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info:eu-repo/semantics/article info:eu-repo/semantics/other |
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http://hdl.handle.net/10183/119170 |
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1807-5932 |
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000953923 |
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eng |
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dc.relation.ispartof.pt_BR.fl_str_mv |
Clinics. São Paulo. Vol. 69, n. 8 (Ago. 2014), p. 547-553 |
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