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临床试验/NCT01616446
NCT01616446已完成不适用

PHARMACOKINETICS OF CYCLOSPORIN - A MICROEMULSION IN CHILDREN WITH IDIOPATHIC NEPHROTIC SYNDROME

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1

研究概览

简要总结

The purpose of this study is to evaluate whether there are differences in the pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease in children.

详细描述

This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the 12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples. This procedure was done on each patient during remission and relapse with the same CSA dose in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12. This study is very important because the cyclosporin is a nephrotoxic drug with narrow therapeutic window.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children with steroid-resistant nephrotic syndrome and steroid-dependent nephrotic syndrome in use of cyclosporine
  • renal function evaluated by creatinine clearance estimated by stature ≥ 90 ml/min/1.73m2
  • cyclosporine trough level (C0) between 50 and 150 ng/ml
  • complete remission with cyclosporine according to the guidelines of International Society of Kidney Diseases in Children

排除标准

  • renal and hepatic function abnormalities
  • presence of infectious disease
  • clinical or histological signs of CSA nephrotoxicity and suspicious of non-compliance

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciana dos Santos Henriques

principal investigator

University of Sao Paulo

研究点 (1)

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