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临床试验/NCT04818177
NCT04818177已完成不适用

Optimization of Dosing of Immunoglobulin G in the Obese Population

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Serum IgG concentrations

研究概览

简要总结

The overall goal of this proposal is to investigate effects of obesity on pharmacokinetics of immunoglobulin G (IgG) and to develop strategies for optimization of dosing of IgG in obese patients. There is an ongoing debate regarding the most appropriate dosing of IgG formulations in obese patients. Obesity poses significant health risks; and evidence supporting dosing strategies of IgG in obese patients is inadequate. Some of the adverse reactions have been attributed to a relative overdosing in these patients, due to a limited distribution of IgG into fat tissue.

详细描述

The estimated prevalence of overweight and obese individuals >20 years in the US is 154.7 million (nearly double since the early 1960s), and over 1.6 billion people are considered overweight or obese worldwide. Compounding the health risks associated with obesity is the insufficient data supporting dosing strategies for a variety of medication used to treat conditions encountered in obese patients. No consensus on the best dosing strategy for IgG in obese patients has been established. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing are being utilized by different institutions. Thus, there is an urgent need to identify evidence supporting optimal dosing strategies for IgG.

It has been proposed that using TBW to dose IgG in obese patients may increase the risk of thrombosis owing to increased blood viscosity, activation of platelets, or vasospasm; and the increase in blood viscosity has been reported as IgG dose dependent. The use of using IBW or AdjBW has been advocated to reduce the side effect and drug expenditures. It is currently unknown what the clinical impact is of using measures of body weight other than TBW to calculate IgG doses, and the effect of obesity on IgG pharmacokinetics has not been experimentally evaluated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 to 75 years
  • currently treated with IVIG

排除标准

  • liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal)
  • reduced renal function (CrCl < 50 mL/min)
  • Patients with a pacemaker or an automatic implantable cardioverter-defibrillator

研究组 & 干预措施

Overweight or Obese

Overweight or obese is defined as BMI > 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.

干预措施: Institutional standard intravenous immune globulin treatment (Drug)

Normal Weight

Normal weight is defined as BMI 18.5 - 25 kg/m2. Subjects will receive the institutional standard intravenous immune globulin treatment.

干预措施: Institutional standard intravenous immune globulin treatment (Drug)

结局指标

主要结局

Serum IgG concentrations

时间窗: 5 time points (baseline, immediately after dose administration (peak), 2 weeks post dose, just prior to receiving the next scheduled dose (trough))

A linear mixed effects model to analyze serum IgG concentrations, with normal/obese as the primary predictor but with clinical and demographic variables as covariates.

次要结局

未报告次要终点

研究者

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

Luigi Brunetti

Associate Professor

Rutgers, The State University of New Jersey

研究点 (1)

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