Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis

Autores
Caletti, María Gracia; Ibáñez, Juan; Caceres Guido, Paulo Arturo; Chertkoff, Lilien Patricia; Bonetto, Mara; Aráoz, Verónica; Schaiquevich, Paula Susana
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Background: Pediatric patients with steroid-resistant nephrotic syndrome (SRNS) and focal segmental glomerulosclerosis (FSGS) may relapse and current second line agents include mycophenolate mofetil. However, there is no current information about the use of the sodium salt of mycophenolic acid (SMPA) in this population.Objectives: We conducted a prospective study on the efficacy and pharmacokinetics of SMPA in children with FSGS.Patients and Methods: Patients without NPHS2 pathogenic variants received SMPA at dosages between 460 to 720 mg/m2/d for 12 months after previous treatments failure. Clinical and biochemical assessments were performed. Blood samples were obtained after the first dose and at steady state (3 months after the onset of treatment) and total and free mycophenolic acid (MPA) was quantitated using HPLC-UV.Results: Two patients showed partial remission after the 12-month period of SMPA treatment with a notable decrease in proteinuria and an increase in serum albumin levels. Maximum MPA concentrations after the first dose and at steady state were 11.6 µg/mL and 10.5 µg/mL, respectively, without drug accumulation. Maximum MPA free levels after the first dose and at steady state were 192.9 and 120.6 ng/mL, respectively. MPA levels became undetectable after 4 hours of the administration in all cases.Conclusions: SMPA is a promising agent for pediatric patients with SRNS and FSGS but SMPA schedule of treatment should be revised with shorter intervals of administration and higher doses than those used in the present study in order to attain higher systemic exposures and accumulation of the immunosuppressant drug. Further efficacy and pharmacokinetic studies should be performed to confirm these findings.
Fil: Caletti, María Gracia. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Ibáñez, Juan. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Caceres Guido, Paulo Arturo. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Chertkoff, Lilien Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Bonetto, Mara. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Aráoz, Verónica. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Schaiquevich, Paula Susana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Materia
FOCAL SEGMENTAL GLOMERULOSCLEROSIS
PEDIATRICS
STEROID-RESISTANT NEPHROTIC SYNDROME
SODIUM MYCOPHENOLATE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/162655
Acceder
id CONICETDig_6865e8404cd748cf39bec6ba9a00ec48
oai_identifier_str oai:ri.conicet.gov.ar:11336/162655
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosisCaletti, María GraciaIbáñez, JuanCaceres Guido, Paulo ArturoChertkoff, Lilien PatriciaBonetto, MaraAráoz, VerónicaSchaiquevich, Paula SusanaFOCAL SEGMENTAL GLOMERULOSCLEROSISPEDIATRICSSTEROID-RESISTANT NEPHROTIC SYNDROMESODIUM MYCOPHENOLATEhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3Background: Pediatric patients with steroid-resistant nephrotic syndrome (SRNS) and focal segmental glomerulosclerosis (FSGS) may relapse and current second line agents include mycophenolate mofetil. However, there is no current information about the use of the sodium salt of mycophenolic acid (SMPA) in this population.Objectives: We conducted a prospective study on the efficacy and pharmacokinetics of SMPA in children with FSGS.Patients and Methods: Patients without NPHS2 pathogenic variants received SMPA at dosages between 460 to 720 mg/m2/d for 12 months after previous treatments failure. Clinical and biochemical assessments were performed. Blood samples were obtained after the first dose and at steady state (3 months after the onset of treatment) and total and free mycophenolic acid (MPA) was quantitated using HPLC-UV.Results: Two patients showed partial remission after the 12-month period of SMPA treatment with a notable decrease in proteinuria and an increase in serum albumin levels. Maximum MPA concentrations after the first dose and at steady state were 11.6 µg/mL and 10.5 µg/mL, respectively, without drug accumulation. Maximum MPA free levels after the first dose and at steady state were 192.9 and 120.6 ng/mL, respectively. MPA levels became undetectable after 4 hours of the administration in all cases.Conclusions: SMPA is a promising agent for pediatric patients with SRNS and FSGS but SMPA schedule of treatment should be revised with shorter intervals of administration and higher doses than those used in the present study in order to attain higher systemic exposures and accumulation of the immunosuppressant drug. Further efficacy and pharmacokinetic studies should be performed to confirm these findings.Fil: Caletti, María Gracia. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Ibáñez, Juan. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Caceres Guido, Paulo Arturo. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Chertkoff, Lilien Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Bonetto, Mara. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Aráoz, Verónica. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaFil: Schaiquevich, Paula Susana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; ArgentinaSociety of Diabetic Nephropathy Prevention2018-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/162655Caletti, María Gracia; Ibáñez, Juan; Caceres Guido, Paulo Arturo; Chertkoff, Lilien Patricia; Bonetto, Mara; et al.; Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis; Society of Diabetic Nephropathy Prevention; Journal of Nephropathology; 7; 3; 11-2018; 213-2222251-83632251-8819CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.nephropathol.com/Article/jnp-20180704113940info:eu-repo/semantics/altIdentifier/doi/10.15171/jnp.2018.39info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T12:14:41Zoai:ri.conicet.gov.ar:11336/162655instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-22 12:14:41.569CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
title Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
spellingShingle Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
Caletti, María Gracia
FOCAL SEGMENTAL GLOMERULOSCLEROSIS
PEDIATRICS
STEROID-RESISTANT NEPHROTIC SYNDROME
SODIUM MYCOPHENOLATE
title_short Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
title_full Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
title_fullStr Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
title_full_unstemmed Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
title_sort Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis
dc.creator.none.fl_str_mv Caletti, María Gracia
Ibáñez, Juan
Caceres Guido, Paulo Arturo
Chertkoff, Lilien Patricia
Bonetto, Mara
Aráoz, Verónica
Schaiquevich, Paula Susana
author Caletti, María Gracia
author_facet Caletti, María Gracia
Ibáñez, Juan
Caceres Guido, Paulo Arturo
Chertkoff, Lilien Patricia
Bonetto, Mara
Aráoz, Verónica
Schaiquevich, Paula Susana
author_role author
author2 Ibáñez, Juan
Caceres Guido, Paulo Arturo
Chertkoff, Lilien Patricia
Bonetto, Mara
Aráoz, Verónica
Schaiquevich, Paula Susana
author2_role author
author
author
author
author
author
dc.subject.none.fl_str_mv FOCAL SEGMENTAL GLOMERULOSCLEROSIS
PEDIATRICS
STEROID-RESISTANT NEPHROTIC SYNDROME
SODIUM MYCOPHENOLATE
topic FOCAL SEGMENTAL GLOMERULOSCLEROSIS
PEDIATRICS
STEROID-RESISTANT NEPHROTIC SYNDROME
SODIUM MYCOPHENOLATE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Background: Pediatric patients with steroid-resistant nephrotic syndrome (SRNS) and focal segmental glomerulosclerosis (FSGS) may relapse and current second line agents include mycophenolate mofetil. However, there is no current information about the use of the sodium salt of mycophenolic acid (SMPA) in this population.Objectives: We conducted a prospective study on the efficacy and pharmacokinetics of SMPA in children with FSGS.Patients and Methods: Patients without NPHS2 pathogenic variants received SMPA at dosages between 460 to 720 mg/m2/d for 12 months after previous treatments failure. Clinical and biochemical assessments were performed. Blood samples were obtained after the first dose and at steady state (3 months after the onset of treatment) and total and free mycophenolic acid (MPA) was quantitated using HPLC-UV.Results: Two patients showed partial remission after the 12-month period of SMPA treatment with a notable decrease in proteinuria and an increase in serum albumin levels. Maximum MPA concentrations after the first dose and at steady state were 11.6 µg/mL and 10.5 µg/mL, respectively, without drug accumulation. Maximum MPA free levels after the first dose and at steady state were 192.9 and 120.6 ng/mL, respectively. MPA levels became undetectable after 4 hours of the administration in all cases.Conclusions: SMPA is a promising agent for pediatric patients with SRNS and FSGS but SMPA schedule of treatment should be revised with shorter intervals of administration and higher doses than those used in the present study in order to attain higher systemic exposures and accumulation of the immunosuppressant drug. Further efficacy and pharmacokinetic studies should be performed to confirm these findings.
Fil: Caletti, María Gracia. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Ibáñez, Juan. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Caceres Guido, Paulo Arturo. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Chertkoff, Lilien Patricia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Bonetto, Mara. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Aráoz, Verónica. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
Fil: Schaiquevich, Paula Susana. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
description Background: Pediatric patients with steroid-resistant nephrotic syndrome (SRNS) and focal segmental glomerulosclerosis (FSGS) may relapse and current second line agents include mycophenolate mofetil. However, there is no current information about the use of the sodium salt of mycophenolic acid (SMPA) in this population.Objectives: We conducted a prospective study on the efficacy and pharmacokinetics of SMPA in children with FSGS.Patients and Methods: Patients without NPHS2 pathogenic variants received SMPA at dosages between 460 to 720 mg/m2/d for 12 months after previous treatments failure. Clinical and biochemical assessments were performed. Blood samples were obtained after the first dose and at steady state (3 months after the onset of treatment) and total and free mycophenolic acid (MPA) was quantitated using HPLC-UV.Results: Two patients showed partial remission after the 12-month period of SMPA treatment with a notable decrease in proteinuria and an increase in serum albumin levels. Maximum MPA concentrations after the first dose and at steady state were 11.6 µg/mL and 10.5 µg/mL, respectively, without drug accumulation. Maximum MPA free levels after the first dose and at steady state were 192.9 and 120.6 ng/mL, respectively. MPA levels became undetectable after 4 hours of the administration in all cases.Conclusions: SMPA is a promising agent for pediatric patients with SRNS and FSGS but SMPA schedule of treatment should be revised with shorter intervals of administration and higher doses than those used in the present study in order to attain higher systemic exposures and accumulation of the immunosuppressant drug. Further efficacy and pharmacokinetic studies should be performed to confirm these findings.
publishDate 2018
dc.date.none.fl_str_mv 2018-11
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/162655
Caletti, María Gracia; Ibáñez, Juan; Caceres Guido, Paulo Arturo; Chertkoff, Lilien Patricia; Bonetto, Mara; et al.; Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis; Society of Diabetic Nephropathy Prevention; Journal of Nephropathology; 7; 3; 11-2018; 213-222
2251-8363
2251-8819
CONICET Digital
CONICET
url http://hdl.handle.net/11336/162655
identifier_str_mv Caletti, María Gracia; Ibáñez, Juan; Caceres Guido, Paulo Arturo; Chertkoff, Lilien Patricia; Bonetto, Mara; et al.; Administration of enteric-coated mycophenolate sodium in children with steroid-resistant nephrotic syndrome and focal segmental glomerulosclerosis; Society of Diabetic Nephropathy Prevention; Journal of Nephropathology; 7; 3; 11-2018; 213-222
2251-8363
2251-8819
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.nephropathol.com/Article/jnp-20180704113940
info:eu-repo/semantics/altIdentifier/doi/10.15171/jnp.2018.39
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Society of Diabetic Nephropathy Prevention
publisher.none.fl_str_mv Society of Diabetic Nephropathy Prevention
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1846782556332097536
score 12.982451

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