Pharmacokinetics of cyclosporin - a microemulsion in children with idiopathic nephrotic syndrome

• Grant number: 12/12285-7
• Support Opportunities: Regular Research Grants - Publications - Scientific article
• Start date: August 01, 2012
• End date: January 31, 2013
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Maria Helena Vaisbich
• Grantee: Maria Helena Vaisbich
• Host Institution: Instituto da Criança Professor Doutor Pedro de Alcantara (ICR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

We report a prospective study in ten children (mean age at presentation, 3.0 ± 1.6 years) using Cyclosporin- a microemulsion (CSA) to treat Idiopathic Nephrotic Syndrome (INS), with normal renal function evaluated by creatinine clearance estimated by stature, who presented C0 (trough level) between 50 and 150 ng/ml and achieved complete remission with CSA. The objective is to compare the pharmacokinetic parameters of CSA between nephrotic children on remission and relapse of the nephrotic state. The pharmacokinetic profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time sample points. This procedure was done in the same patient during remission and relapse with the same dose of CSA (mg/kg). The AUC0-12 was calculated by trapezoidal rule. All points of the curve and the resumed AUC0-4 was compared with AUC0-12. We detected no significant differences at any points of the curve during remission and relapse, even when data were normalized by dose (mg/kg). Our study has shown that AUC0-4 was the main point on both states of the disease, remission and relapse, when compared to AUC0-12 (r=0.95 on remission and r=0.93 on relapse), and the second parameter found was C2 (r=0.86 on remission and r=0.80 on relapse). More controlled studies are needed to reproduce the findings and confirm this proposition. The target C2 concentration needs to be determined for INS in children to avoid adverse effects while promoting efficacy. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

HENRIQUES, LUCIANA DOS SANTOS; MATOS, FABIOLA DE MARCOS; VAISBICH, MARIA HELENA. Pharmacokinetics of cyclosporin - a microemulsion in children with idiopathic nephrotic syndrome. Clinics, v. 67, n. 10, p. 1197-1202, 2012. (12/12285-7)

LUCIANA DOS SANTOS HENRIQUES; FABÍOLA DE MARCOS MATOS; MARIA HELENA VAISBICH. Pharmacokinetics of cyclosporin: a microemulsion in children with idiopathic nephrotic syndrome. Clinics, v. 67, n. 10, p. 1197-1202, 2012-10-00. (12/12285-7)