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Pharmacokinetic Evaluation of Nimotuzumab in Patients With Autosomal Dominant Polycystic Kidney Disease.
de Castro-Suárez, Niurys; Rodríguez-Vera, Leyanis; Villegas, Carlos; Dávalos-Iglesias, José M; Bacallao-Mendez, Raymed; Llerena-Ferrer, Betsy; Leyva-de la Torre, Christian; Lorenzo-Luaces, Patricia; Troche-Concepción, Mayelin; Ramos-Suzarte, Mayra.
Afiliação
  • de Castro-Suárez N; Laboratory of Biopharmaceutics, Department of Pharmacology & Toxicology, Institute of Pharmacy & Foods, University of Havana, Havana, Cuba.
  • Rodríguez-Vera L; Laboratory of Biopharmaceutics, Department of Pharmacology & Toxicology, Institute of Pharmacy & Foods, University of Havana, Havana, Cuba.
  • Villegas C; National Institute of Oncology and Radiobiology, Havana, Cuba.
  • Dávalos-Iglesias JM; National Institute of Nephrology, Havana, Cuba.
  • Bacallao-Mendez R; National Institute of Nephrology, Havana, Cuba.
  • Llerena-Ferrer B; National Institute of Nephrology, Havana, Cuba.
  • Leyva-de la Torre C; National Institute of Nephrology, Havana, Cuba.
  • Lorenzo-Luaces P; Center of Molecular Immunology, Havana, Cuba.
  • Troche-Concepción M; Center of Molecular Immunology, Havana, Cuba.
  • Ramos-Suzarte M; Center of Molecular Immunology, Havana, Cuba.
J Clin Pharmacol ; 59(6): 863-871, 2019 06.
Article em En | MEDLINE | ID: mdl-30633365
ABSTRACT
Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disease characterized by an overexpression and mislocalization of epidermal growth factor receptor (EGFR) to the apical membranes of cystic epithelial cells. Nimotuzumab is a humanized antibody that recognizes an extracellular domain III of human EGFR. The aim of this study was to assess the pharmacokinetic behavior of nimotuzumab in patients with ADPKD given as a single dose. A phase I, single-center, and noncontrolled open clinical study was conducted. Five patients were enrolled at each of the following fixed-dose levels 50, 100, 200, and 400 mg. Intravenous continuous infusions of nimotuzumab were administered every 14 days during a year, except the first administration, when blood samples were drawn during 28 days for pharmacokinetic assessments. Subjects were closely monitored during the trial and at completion of the administration of nimotuzumab, including the anti-idiotypic response. For the first time, nimotuzumab was used for treating a nononcological disease. The administration of nimotuzumab showed dose-dependent kinetics. Nimotuzumab does not develop anti-idiotypic response against the murine portion present in the hypervariable region of the antibody present in the serum of the patients treated. No significant differences were found in the systemic clearance between the 100- and 400-mg dose, which indicates that the optimal biological dose is in this range of dose.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Rim Policístico Autossômico Dominante / Anticorpos Monoclonais Humanizados Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Rim Policístico Autossômico Dominante / Anticorpos Monoclonais Humanizados Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Pharmacol Ano de publicação: 2019 Tipo de documento: Article